Trial Outcomes & Findings for Vaccination of High Risk Breast Cancer Patients (NCT NCT02229084)
NCT ID: NCT02229084
Last Updated: 2024-11-07
Results Overview
Number of participants with sufficiently high anti-P10s immunoglobulin-G response Feasibility will be evaluated in terms of 1. Generation of a sufficiently high anti-P10s immunoglobulin-G response 2. Safety and tolerability of the combination of vaccine and chemotherapy
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
58 participants
Primary outcome timeframe
At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)
Results posted on
2024-11-07
Participant Flow
Potential subjects were recruited from the Winthrop P Rockefeller Cancer Institute on the University of Arkansas for Medical Sciences campus and clinics at Highlands Oncology Group.
Participant milestones
| Measure |
Part 1 - Chemovax Schedule A
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 - Chemovax Schedule C
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 3 - Chemovax Schedule C
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
5
|
19
|
14
|
|
Overall Study
COMPLETED
|
4
|
5
|
3
|
3
|
1
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
2
|
4
|
1
|
4
|
Reasons for withdrawal
| Measure |
Part 1 - Chemovax Schedule A
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 - Chemovax Schedule C
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 3 - Chemovax Schedule C
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
3
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
1
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
For 1 participant in Part 2, ECOG Performance was not given.
Baseline characteristics by cohort
| Measure |
Part 1 - Chemovax Schedule A
n=5 Participants
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
n=5 Participants
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
n=5 Participants
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
n=5 Participants
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
n=5 Participants
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 - Chemovax Schedule C
n=19 Participants
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 3 - Chemovax Schedule C
n=14 Participants
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=58 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=19 Participants
|
13 Participants
n=14 Participants
|
49 Participants
n=58 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=14 Participants
|
9 Participants
n=58 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
53 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 15.42 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 15.24 • n=5 Participants
|
52.58 years
STANDARD_DEVIATION 10.73 • n=19 Participants
|
46.86 years
STANDARD_DEVIATION 10.73 • n=14 Participants
|
50.15 years
STANDARD_DEVIATION 10.94 • n=58 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=19 Participants
|
14 Participants
n=14 Participants
|
58 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=19 Participants
|
6 Participants
n=14 Participants
|
16 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=19 Participants
|
6 Participants
n=14 Participants
|
40 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=14 Participants
|
2 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=19 Participants
|
3 Participants
n=14 Participants
|
9 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=19 Participants
|
8 Participants
n=14 Participants
|
45 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=58 Participants
|
|
Region of Enrollment
United States · Central Arkansas at University of Arkansas for Medical Sciences
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=19 Participants
|
14 Participants
n=14 Participants
|
37 Participants
n=58 Participants
|
|
Region of Enrollment
United States · Northwest Arkansas at Highlands Oncology Group
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
21 Participants
n=58 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 Fully active, able to carry on all pre-disease
|
4 Participants
n=5 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
5 Participants
n=5 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
5 Participants
n=5 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
4 Participants
n=5 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
4 Participants
n=5 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
18 Participants
n=19 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
13 Participants
n=14 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
53 Participants
n=58 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 Restricted in physically strenuous activity but ambulatory and able to carry out work
|
1 Participants
n=5 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
0 Participants
n=5 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
0 Participants
n=5 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
1 Participants
n=5 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
1 Participants
n=5 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
1 Participants
n=19 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
1 Participants
n=14 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
5 Participants
n=58 Participants • For 1 participant in Part 2, ECOG Performance was not given.
|
|
Pre-Treatment Tumor Size
|
2.9 centimeters
STANDARD_DEVIATION .84 • n=5 Participants • For 1 participant in Part 3, pre-treatment tumor size was not reported.
|
4.06 centimeters
STANDARD_DEVIATION 1.44 • n=5 Participants • For 1 participant in Part 3, pre-treatment tumor size was not reported.
|
4.82 centimeters
STANDARD_DEVIATION 2.03 • n=5 Participants • For 1 participant in Part 3, pre-treatment tumor size was not reported.
|
3.76 centimeters
STANDARD_DEVIATION 2.56 • n=5 Participants • For 1 participant in Part 3, pre-treatment tumor size was not reported.
|
1.96 centimeters
STANDARD_DEVIATION 0.82 • n=5 Participants • For 1 participant in Part 3, pre-treatment tumor size was not reported.
|
4.13 centimeters
STANDARD_DEVIATION 2.67 • n=19 Participants • For 1 participant in Part 3, pre-treatment tumor size was not reported.
|
5.43 centimeters
STANDARD_DEVIATION 2.19 • n=13 Participants • For 1 participant in Part 3, pre-treatment tumor size was not reported.
|
4.03 centimeters
STANDARD_DEVIATION 2.38 • n=57 Participants • For 1 participant in Part 3, pre-treatment tumor size was not reported.
|
|
American Joint Committee on Cancer (AJCC) Tumor Staging
Stage IA
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
2 Participants
n=18 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=14 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
4 Participants
n=57 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
|
American Joint Committee on Cancer (AJCC) Tumor Staging
Stage IB
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=18 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=14 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=57 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
|
American Joint Committee on Cancer (AJCC) Tumor Staging
Stage II
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=18 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
3 Participants
n=14 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
5 Participants
n=57 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
|
American Joint Committee on Cancer (AJCC) Tumor Staging
Stage IIA
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
2 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
4 Participants
n=18 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
2 Participants
n=14 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
11 Participants
n=57 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
|
American Joint Committee on Cancer (AJCC) Tumor Staging
Stage IIB
|
3 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
2 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
2 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
4 Participants
n=18 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
4 Participants
n=14 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
17 Participants
n=57 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
|
American Joint Committee on Cancer (AJCC) Tumor Staging
Stage III
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
3 Participants
n=18 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
2 Participants
n=14 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
6 Participants
n=57 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
|
American Joint Committee on Cancer (AJCC) Tumor Staging
Stage IIIA
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
2 Participants
n=18 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=14 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
4 Participants
n=57 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
|
American Joint Committee on Cancer (AJCC) Tumor Staging
Stage IIIB
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
2 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
2 Participants
n=18 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=14 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
8 Participants
n=57 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
|
American Joint Committee on Cancer (AJCC) Tumor Staging
Stage not reported/given
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=5 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=18 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
0 Participants
n=14 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
1 Participants
n=57 Participants • For 2 participants, both in Part 2, AJCC stage was not given.
|
|
Tumor Grade
Grade I
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=14 Participants
|
6 Participants
n=58 Participants
|
|
Tumor Grade
Grade II
|
2 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=19 Participants
|
4 Participants
n=14 Participants
|
26 Participants
n=58 Participants
|
|
Tumor Grade
Grade III
|
3 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=19 Participants
|
6 Participants
n=14 Participants
|
25 Participants
n=58 Participants
|
|
Tumor Grade
Grade X (Unknown)
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=58 Participants
|
|
Tumor Type
Luminal A
|
2 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
12 Participants
n=58 Participants
|
|
Tumor Type
Luminal B
|
3 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
13 Participants
n=58 Participants
|
|
Tumor Type
Not collected
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
19 Participants
n=19 Participants
|
14 Participants
n=14 Participants
|
33 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)Population: This was defined as a \>4-fold increase in a subject's anti-P10s-MAP IgG titer at Week 7 or later (at least 4 weeks after the 3rd immunization) relative to her pre-immune titer. For 1 participant, the Week 7 antibody titer was NA.
Number of participants with sufficiently high anti-P10s immunoglobulin-G response Feasibility will be evaluated in terms of 1. Generation of a sufficiently high anti-P10s immunoglobulin-G response 2. Safety and tolerability of the combination of vaccine and chemotherapy
Outcome measures
| Measure |
Part 1 - Chemovax Schedule A
n=5 Participants
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
n=5 Participants
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
n=5 Participants
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
n=5 Participants
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
n=5 Participants
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 - Chemovax Schedule C
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 3 - Chemovax Schedule C
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
|---|---|---|---|---|---|---|---|
|
Identify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently.
Greater than or equal to 4-fold increase
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Identify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently.
Less than 4-fold increase
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)Population: Clinical Response was determined for participants in Part 2 and 3. Part 2 Chemovax Schedule C was Stage 1 of the Simon 2-stage design. Stage 1's efficacy decision was a rule-based decision. If Stage 1 had 2 or more pCRs, then we could open up Stage 2 and start enrolling patients on it. Part 3 Chemovax Schedule C was Stage 2 of the Simon 2-stage design. It was supposed to enroll 22 subjects, but it had enrolled only 14 subjects by the time the study was closed to enrollment.
The patient-level primary outcome for this objective is pathological Complete Response (pCR), which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes. The patient is assessed at the time of surgery for whether they achieved pCR=yes. They have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment. Pathological Complete Response is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0N0 or ypTisN0 in the AJCC staging system for staging solid tumors in the neoadjuvant setting that was described in a 2014 FDA Guidance for Industry).
Outcome measures
| Measure |
Part 1 - Chemovax Schedule A
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 - Chemovax Schedule C
n=19 Participants
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 3 - Chemovax Schedule C
n=14 Participants
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
|---|---|---|---|---|---|---|---|
|
Determine the pCR Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 1 through Week 70The anti-P10s binding level was measured via ELISA method after incubation with a subject's serum or plasma sample. Data was collected at multiple timepoints throughout the study. Values were averaged for each group.
Outcome measures
| Measure |
Part 1 - Chemovax Schedule A
n=5 Participants
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
n=5 Participants
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
n=5 Participants
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
n=5 Participants
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
n=5 Participants
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 - Chemovax Schedule C
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 3 - Chemovax Schedule C
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
|---|---|---|---|---|---|---|---|
|
P10s-MAP-Reactive Immunoglobulin Titers
|
10.72 titers
Standard Deviation 14.97
|
9.76 titers
Standard Deviation 13.91
|
42.25 titers
Standard Deviation 71.94
|
4.38 titers
Standard Deviation 5.10
|
6.74 titers
Standard Deviation 7
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 through Week 70Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample. Data was collected at multiple timepoints throughout the study. Values were averaged for each group. For some participants, CD16 was not assessable.
Outcome measures
| Measure |
Part 1 - Chemovax Schedule A
n=5 Participants
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
n=5 Participants
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
n=5 Participants
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
n=5 Participants
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
n=4 Participants
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 - Chemovax Schedule C
n=19 Participants
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 3 - Chemovax Schedule C
n=14 Participants
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
|---|---|---|---|---|---|---|---|
|
Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD16
Pre-Immune CD16
|
26065 Median Fluorescence Intensity (MFI)
Standard Deviation 7976.46
|
26580 Median Fluorescence Intensity (MFI)
Standard Deviation 2261.51
|
25171.8 Median Fluorescence Intensity (MFI)
Standard Deviation 6493
|
28546 Median Fluorescence Intensity (MFI)
Standard Deviation 7197.16
|
24897 Median Fluorescence Intensity (MFI)
Standard Deviation 5334.72
|
67445.83 Median Fluorescence Intensity (MFI)
Standard Deviation 31389.28
|
68619.59 Median Fluorescence Intensity (MFI)
Standard Deviation 27944.66
|
|
Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD16
Post-Immune CD16
|
19745.4 Median Fluorescence Intensity (MFI)
Standard Deviation 5182.72
|
20993.4 Median Fluorescence Intensity (MFI)
Standard Deviation 7061.48
|
27998.6 Median Fluorescence Intensity (MFI)
Standard Deviation 10142.41
|
22959.8 Median Fluorescence Intensity (MFI)
Standard Deviation 6020.06
|
25711.75 Median Fluorescence Intensity (MFI)
Standard Deviation 20572.69
|
62323.05 Median Fluorescence Intensity (MFI)
Standard Deviation 24021.75
|
65410.12 Median Fluorescence Intensity (MFI)
Standard Deviation 24645.52
|
SECONDARY outcome
Timeframe: Week 1 through Week 70Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample. Data was collected at multiple timepoints throughout the study. Values were averaged for each group. For some participants, CD69 was not assessable.
Outcome measures
| Measure |
Part 1 - Chemovax Schedule A
n=5 Participants
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
n=5 Participants
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
n=5 Participants
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
n=5 Participants
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
n=4 Participants
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 - Chemovax Schedule C
n=19 Participants
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 3 - Chemovax Schedule C
n=14 Participants
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
|---|---|---|---|---|---|---|---|
|
Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD69
Pre-Immune CD69
|
268.2 Median Fluorescence Intensity (MFI)
Standard Deviation 50.08
|
300.8 Median Fluorescence Intensity (MFI)
Standard Deviation 88.02
|
291.4 Median Fluorescence Intensity (MFI)
Standard Deviation 38.55
|
294.6 Median Fluorescence Intensity (MFI)
Standard Deviation 57.27
|
296.25 Median Fluorescence Intensity (MFI)
Standard Deviation 34.37
|
428 Median Fluorescence Intensity (MFI)
Standard Deviation 133
|
445.5 Median Fluorescence Intensity (MFI)
Standard Deviation 169.17
|
|
Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD69
Post-Immune CD69
|
307 Median Fluorescence Intensity (MFI)
Standard Deviation 72.29
|
329.6 Median Fluorescence Intensity (MFI)
Standard Deviation 26.23
|
275 Median Fluorescence Intensity (MFI)
Standard Deviation 25.25
|
278.4 Median Fluorescence Intensity (MFI)
Standard Deviation 27.87
|
311.25 Median Fluorescence Intensity (MFI)
Standard Deviation 16.76
|
489.44 Median Fluorescence Intensity (MFI)
Standard Deviation 139.9
|
505.97 Median Fluorescence Intensity (MFI)
Standard Deviation 161.11
|
SECONDARY outcome
Timeframe: Week 1 through Week 70Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample. Data was collected at multiple timepoints throughout the study. Values were averaged for each group. For some participants, NKp46 was not assessable.
Outcome measures
| Measure |
Part 1 - Chemovax Schedule A
n=5 Participants
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
n=5 Participants
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
n=5 Participants
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
n=5 Participants
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
n=4 Participants
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 - Chemovax Schedule C
n=19 Participants
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 3 - Chemovax Schedule C
n=14 Participants
Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
|---|---|---|---|---|---|---|---|
|
Activation Profiles of NK Cells: Pre-Immune and Post-Immune NKp46
Pre-Immune NKp46
|
685.2 Median Fluorescence Intensity (MFI)
Standard Deviation 390.469
|
590.4 Median Fluorescence Intensity (MFI)
Standard Deviation 204.147
|
724.2 Median Fluorescence Intensity (MFI)
Standard Deviation 422.436
|
794.2 Median Fluorescence Intensity (MFI)
Standard Deviation 355.618
|
744.25 Median Fluorescence Intensity (MFI)
Standard Deviation 251.998
|
1360.33 Median Fluorescence Intensity (MFI)
Standard Deviation 638.97
|
1650.08 Median Fluorescence Intensity (MFI)
Standard Deviation 878.64
|
|
Activation Profiles of NK Cells: Pre-Immune and Post-Immune NKp46
Post-Immune NKp46
|
1391 Median Fluorescence Intensity (MFI)
Standard Deviation 489.819
|
1115.6 Median Fluorescence Intensity (MFI)
Standard Deviation 485.348
|
1084.2 Median Fluorescence Intensity (MFI)
Standard Deviation 930.867
|
1168.2 Median Fluorescence Intensity (MFI)
Standard Deviation 324.282
|
1505.5 Median Fluorescence Intensity (MFI)
Standard Deviation 1031.69
|
1412.13 Median Fluorescence Intensity (MFI)
Standard Deviation 645.68
|
1813.56 Median Fluorescence Intensity (MFI)
Standard Deviation 879.38
|
Adverse Events
Part 1 - Chemovax Schedule A
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 - Chemovax Schedule B
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 - Chemovax Schedule C
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 - Chemovax Schedule D
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 - Chemovax Schedule E
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2 & 3 Combined - Chemovax Schedule C
Serious events: 19 serious events
Other events: 33 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part 1 - Chemovax Schedule A
n=5 participants at risk
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
n=5 participants at risk
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
n=5 participants at risk
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
n=5 participants at risk
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
n=5 participants at risk
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 & 3 Combined - Chemovax Schedule C
n=33 participants at risk
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
The 33 subjects combined from Parts 2 and 3 had the exact same treatment (Schedule C). The final efficacy evaluation required us to combine the pCRs from both parts.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 15 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Mucositis Oral
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Vomitting
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
15.2%
5/33 • Number of events 13 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
15.2%
5/33 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
White blood cell decreased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
15.2%
5/33 • Number of events 9 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Vascular disorders
Thromboembolic event
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Cardiac disorders
Cardia disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Fever
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Flu like symptoms
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Breast infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
GGT increased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
Other adverse events
| Measure |
Part 1 - Chemovax Schedule A
n=5 participants at risk
Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule B
n=5 participants at risk
Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule C
n=5 participants at risk
Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule D
n=5 participants at risk
Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 1 - Chemovax Schedule E
n=5 participants at risk
Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
|
Part 2 & 3 Combined - Chemovax Schedule C
n=33 participants at risk
Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
The 33 subjects combined from Parts 2 and 3 had the exact same treatment (Schedule C). The final efficacy evaluation required us to combine the pCRs from both parts.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
100.0%
5/5 • Number of events 27 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
100.0%
5/5 • Number of events 11 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 10 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
87.9%
29/33 • Number of events 144 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Ear and labyrinth disorders
Vertigo
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
15.2%
5/33 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Blurred vision
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Dry Eye
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Eye Pain
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Watering eyes
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
36.4%
12/33 • Number of events 13 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
33.3%
11/33 • Number of events 17 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
80.0%
4/5 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
66.7%
22/33 • Number of events 34 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.6%
20/33 • Number of events 30 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
39.4%
13/33 • Number of events 16 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
24.2%
8/33 • Number of events 14 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Hemorrhoids
|
60.0%
3/5 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Mucositis oral
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
27.3%
9/33 • Number of events 15 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
80.0%
4/5 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
80.0%
4/5 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
100.0%
5/5 • Number of events 8 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
80.0%
4/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
87.9%
29/33 • Number of events 72 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Vomitting
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
51.5%
17/33 • Number of events 29 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Chills
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
21.2%
7/33 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Edema limbs
|
80.0%
4/5 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
27.3%
9/33 • Number of events 11 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Edema trunk
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
80.0%
4/5 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
80.0%
4/5 • Number of events 11 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
100.0%
5/5 • Number of events 19 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
90.9%
30/33 • Number of events 80 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Fever
|
60.0%
3/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
General disorders and administration
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
27.3%
9/33 • Number of events 15 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Injection site reaction
|
80.0%
4/5 • Number of events 8 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
100.0%
5/5 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
100.0%
5/5 • Number of events 9 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
100.0%
5/5 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
100.0%
5/5 • Number of events 8 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
90.9%
30/33 • Number of events 49 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
45.5%
15/33 • Number of events 26 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Breast infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Bronchial infection
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
36.4%
12/33 • Number of events 16 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Skin infection
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
21.2%
7/33 • Number of events 8 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 8 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
27.3%
9/33 • Number of events 15 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
45.5%
15/33 • Number of events 21 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
30.3%
10/33 • Number of events 17 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Creatinine increased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
15.2%
5/33 • Number of events 20 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
GGT increased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 9 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
75.8%
25/33 • Number of events 143 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Lymphocyte count decreased
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
100.0%
5/5 • Number of events 13 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
80.0%
4/5 • Number of events 11 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
78.8%
26/33 • Number of events 121 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 13 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
100.0%
5/5 • Number of events 8 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
54.5%
18/33 • Number of events 36 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
24.2%
8/33 • Number of events 20 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Weight gain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
39.4%
13/33 • Number of events 35 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
48.5%
16/33 • Number of events 23 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
39.4%
13/33 • Number of events 26 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
39.4%
13/33 • Number of events 42 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
48.5%
16/33 • Number of events 48 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
30.3%
10/33 • Number of events 23 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
33.3%
11/33 • Number of events 17 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
40.0%
2/5 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
51.5%
17/33 • Number of events 25 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
42.4%
14/33 • Number of events 21 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 11 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
39.4%
13/33 • Number of events 21 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
80.0%
4/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
42.4%
14/33 • Number of events 20 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
54.5%
18/33 • Number of events 23 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
45.5%
15/33 • Number of events 20 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Dysgeusia
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 9 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
66.7%
22/33 • Number of events 42 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Memory impairment
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Parethesia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
30.3%
10/33 • Number of events 13 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
30.3%
10/33 • Number of events 11 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
57.6%
19/33 • Number of events 31 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
36.4%
12/33 • Number of events 17 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
80.0%
4/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
54.5%
18/33 • Number of events 30 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Psychiatric disorders
Personality change
|
20.0%
1/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
21.2%
7/33 • Number of events 8 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Urinary frequency
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Urinary retention
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Breast pain
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
27.3%
9/33 • Number of events 19 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorder - Other, specify
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
21.2%
7/33 • Number of events 10 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
15.2%
5/33 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
36.4%
12/33 • Number of events 16 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
33.3%
11/33 • Number of events 15 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
15.2%
5/33 • Number of events 8 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 8 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
24.2%
8/33 • Number of events 10 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
60.0%
3/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
57.6%
19/33 • Number of events 24 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Erythema multifore
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/33 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 10 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
21.2%
7/33 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
66.7%
22/33 • Number of events 39 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Vascular disorders
Flushing
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
48.5%
16/33 • Number of events 20 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
36.4%
12/33 • Number of events 18 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 7 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
15.2%
5/33 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Cataract
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Flashing lights
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Glaucoma
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Photophobia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
18.2%
6/33 • Number of events 12 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Edema face
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Facial pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Localized edema
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Malaise
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
21.2%
7/33 • Number of events 10 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Otitis media
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
15.2%
5/33 • Number of events 12 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Cholesterol high
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
INR increased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Metabolism and nutrition disorders
Metabolisms and nutrition disorders - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
33.3%
11/33 • Number of events 17 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
24.2%
8/33 • Number of events 12 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
dysesthesia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Spasticity
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Irregular menstruatino
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Premature menopause
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 3 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Vaginal hemorrhgae
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Body odor
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
6.1%
2/33 • Number of events 2 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 4 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Social circumstances
Social circumstances - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
0.00%
0/5 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
12.1%
4/33 • Number of events 6 • Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place