Trial Outcomes & Findings for A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002) (NCT NCT00753415)
NCT ID: NCT00753415
Last Updated: 2015-03-17
Results Overview
DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
Results posted on
2015-03-17
Participant Flow
V935 alone or in combination with V934 was administered to 37 participants with selected solid tumors in Part A.
Of the 37 participants who were enrolled in Part A, 32 participants completed and were eligible to enroll in the optional extension study Part B. There were 28 participants who elected to enroll in Part B.
Participant milestones
| Measure |
Part A: V935 LD
Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
|
Part A: V934 LD(3)+V935 LD
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
|
Part A: V935 HD
Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
|
Part A: V934 HD(3)+V935 HD
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part A: V934 HD(5)+V935 HD
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part B: V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
|
Part B: V934 LD(3)+V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(3)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(5)+V934 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A
STARTED
|
3
|
3
|
10
|
11
|
10
|
0
|
0
|
0
|
0
|
0
|
|
Part A
COMPLETED
|
2
|
3
|
8
|
9
|
10
|
0
|
0
|
0
|
0
|
0
|
|
Part A
NOT COMPLETED
|
1
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
7
|
9
|
9
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
6
|
6
|
8
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Part A: V935 LD
Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
|
Part A: V934 LD(3)+V935 LD
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
|
Part A: V935 HD
Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
|
Part A: V934 HD(3)+V935 HD
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part A: V934 HD(5)+V935 HD
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part B: V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
|
Part B: V934 LD(3)+V935 LD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(3)+V935 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(5)+V934 HD/V934 Booster
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A
Disease progression
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Part B
Disease progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
Baseline characteristics by cohort
| Measure |
Part A: V935 LD
n=3 Participants
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
|
Part A: V934 LD(3)+V935 LD
n=3 Participants
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
|
Part A: V935 HD
n=10 Participants
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
|
Part A: V934 HD(3)+V935 HD
n=11 Participants
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part A: V934 HD(5)+V935 HD
n=10 Participants
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.0 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
70.0 Years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
63.8 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
58.8 Years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
60.2 Years
STANDARD_DEVIATION 11.7 • n=21 Participants
|
62.4 Years
STANDARD_DEVIATION 11.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) PeriodPopulation: Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.
DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.
Outcome measures
| Measure |
Part A: V935 LD
n=3 Participants
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
|
Part A: V934 LD(3)+V935 LD
n=3 Participants
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
|
Part A: V935 HD
n=10 Participants
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
|
Part A: V934 HD(3)+V935 HD
n=11 Participants
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part A: V934 HD(5)+V935 HD
n=10 Participants
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part B: V935 LD/V934 Booster
n=1 Participants
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 LD(3)+V935 LD/V934 Booster
n=2 Participants
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V935 HD/V934 Booster
n=7 Participants
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(3)+V935 HD/V934 Booster
n=9 Participants
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(5)+V935 HD/V934 Booster
n=9 Participants
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) PeriodPopulation: All Participants as Treated (APaT) population; all participants who received at least one vaccination.
This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.
Outcome measures
| Measure |
Part A: V935 LD
n=3 Participants
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
|
Part A: V934 LD(3)+V935 LD
n=3 Participants
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
|
Part A: V935 HD
n=10 Participants
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
|
Part A: V934 HD(3)+V935 HD
n=11 Participants
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part A: V934 HD(5)+V935 HD
n=10 Participants
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part B: V935 LD/V934 Booster
n=1 Participants
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 LD(3)+V935 LD/V934 Booster
n=2 Participants
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V935 HD/V934 Booster
n=7 Participants
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(3)+V935 HD/V934 Booster
n=9 Participants
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(5)+V935 HD/V934 Booster
n=9 Participants
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
3 Participants
|
3 Participants
|
8 Participants
|
11 Participants
|
10 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From pre-vaccination to Week 69Population: Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.
An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10\^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.
Outcome measures
Outcome data not reported
Adverse Events
Part A: V935 LD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: V934 LD(3)+V935 LD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: V935 HD
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A: V934 HD(3)+V935 HD
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A: V934 HD(5)+V935 HD
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B: V935 LD/V934 Booster
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: V934 LD(3)+V935 LD/V934 Booster
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: V935 HD/V934 Booster
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: V934 HD(3)+V935 HD/V934 Booster
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B: V934 HD(5)+V935 HD/V934 Booster
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: V935 LD
n=3 participants at risk
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
|
Part A: V934 LD(3)+V935 LD
n=3 participants at risk
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
|
Part A: V935 HD
n=10 participants at risk
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
|
Part A: V934 HD(3)+V935 HD
n=11 participants at risk
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part A: V934 HD(5)+V935 HD
n=10 participants at risk
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part B: V935 LD/V934 Booster
n=1 participants at risk
Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 LD(3)+V935 LD/V934 Booster
n=2 participants at risk
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V935 HD/V934 Booster
n=7 participants at risk
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(3)+V935 HD/V934 Booster
n=9 participants at risk
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(5)+V935 HD/V934 Booster
n=9 participants at risk
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Cardiac disorders
Coronary artery stenosis
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
Other adverse events
| Measure |
Part A: V935 LD
n=3 participants at risk
Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
|
Part A: V934 LD(3)+V935 LD
n=3 participants at risk
Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
|
Part A: V935 HD
n=10 participants at risk
Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
|
Part A: V934 HD(3)+V935 HD
n=11 participants at risk
Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part A: V934 HD(5)+V935 HD
n=10 participants at risk
Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
|
Part B: V935 LD/V934 Booster
n=1 participants at risk
Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 LD(3)+V935 LD/V934 Booster
n=2 participants at risk
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V935 HD/V934 Booster
n=7 participants at risk
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(3)+V935 HD/V934 Booster
n=9 participants at risk
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
Part B: V934 HD(5)+V935 HD/V934 Booster
n=9 participants at risk
Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
27.3%
3/11 • Number of events 3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 4 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
18.2%
2/11 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
20.0%
2/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
27.3%
3/11 • Number of events 3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
20.0%
2/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
14.3%
1/7 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Chills
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Fatigue
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
45.5%
5/11 • Number of events 11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
60.0%
6/10 • Number of events 10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
22.2%
2/9 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 4 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Feeling jittery
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
66.7%
2/3 • Number of events 3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
72.7%
8/11 • Number of events 19 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
60.0%
6/10 • Number of events 17 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
14.3%
1/7 • Number of events 3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
66.7%
6/9 • Number of events 11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
33.3%
3/9 • Number of events 6 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Injection site haematoma
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Injection site induration
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
72.7%
8/11 • Number of events 21 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
90.0%
9/10 • Number of events 38 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
100.0%
1/1 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
50.0%
1/2 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
42.9%
3/7 • Number of events 7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
55.6%
5/9 • Number of events 12 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
77.8%
7/9 • Number of events 14 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Injection site scab
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Injection site scar
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
72.7%
8/11 • Number of events 13 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
60.0%
6/10 • Number of events 6 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
28.6%
2/7 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
44.4%
4/9 • Number of events 6 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
22.2%
2/9 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Nodule
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Oedema
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Pain
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
20.0%
2/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Celllulitis
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Ear lobe infection
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
40.0%
4/10 • Number of events 5 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
18.2%
2/11 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
18.2%
2/11 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Blood amylase increased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Blood urine
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Blood urine present
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Glomerular filtration rate increased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
Protein total increased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
White blood cells urine
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
18.2%
2/11 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
20.0%
2/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
18.2%
2/11 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
18.2%
2/11 • Number of events 3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
20.0%
2/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
20.0%
2/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
20.0%
2/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
18.2%
2/11 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
20.0%
2/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
14.3%
1/7 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
11.1%
1/9 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
22.2%
2/9 • Number of events 2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
General disorders
Injection site mass
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
9.1%
1/11 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Injury, poisoning and procedural complications
Mountain sickness acute
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
10.0%
1/10 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
33.3%
1/3 • Number of events 1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/3 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/11 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/10 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/1 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/2 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/7 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
0.00%
0/9 • SAEs reported for Treatment Period+Acute FU+Chronic FU;Part A: Day 1 up to Wk 69, Part B: Day 1 up to 6 months post last vaccination-Wk 28). Nonserious AEs (Parts A&B) reported for Treatment Period+Acute FU;Day 1 up to 30 days post last vaccination-77 Wks
Participants who completed Part A had the option to enter Part B.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharpe & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER