Trial Outcomes & Findings for Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa... (NCT NCT03952650)
NCT ID: NCT03952650
Last Updated: 2022-07-12
Results Overview
Count of participants with positive sensitive blood smear (sBS) occurring after PfSPZ-CVac immunization starting on day 7 post DVI. Only pilot phase arms (Arms 1a, 2a) were analyzed for this outcome measure. Arms 5a and 6a were not performed, as no patent parasitemia was observed in either Arms 1a or 2a, per the protocol.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
252 participants
Primary outcome timeframe
7 -12 days post-inoculation
Results posted on
2022-07-12
Participant Flow
Per protocol, enrollment occurs with receipt of the first dose of artemether/lumefantrine and collection of baseline study samples on study Day -17.
Participant milestones
| Measure |
1a - Pilot/Safety: Dosing Interval on Days: 1
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ
|
1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
2a - Pilot/Safety: Dosing Interval on Days: 1
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ
|
2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
3a - Pilot/Safety: Dosing Interval on Days: 1
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with chloroquine 2 days prior \& 5 days post PfSPZ
|
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
90
|
4
|
60
|
4
|
54
|
36
|
|
Overall Study
COMPLETED
|
4
|
83
|
4
|
53
|
4
|
47
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
0
|
7
|
0
|
7
|
4
|
Reasons for withdrawal
| Measure |
1a - Pilot/Safety: Dosing Interval on Days: 1
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ
|
1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
2a - Pilot/Safety: Dosing Interval on Days: 1
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ
|
2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
3a - Pilot/Safety: Dosing Interval on Days: 1
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with chloroquine 2 days prior \& 5 days post PfSPZ
|
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Unable to make study visit
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
TRAVEL
|
0
|
4
|
0
|
4
|
0
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
3
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Received wrong vaccine and travelled
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...
Baseline characteristics by cohort
| Measure |
1a - Pilot/Safety: Dosing Interval on Days: 1
n=4 Participants
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ
|
1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
n=90 Participants
Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
2a - Pilot/Safety: Dosing Interval on Days: 1
n=4 Participants
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ
|
2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
n=60 Participants
Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
3a - Pilot/Safety: Dosing Interval on Days: 1
n=4 Participants
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with chloroquine 2 days prior \& 5 days post PfSPZ
|
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57
n=54 Participants
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57
n=36 Participants
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
90 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
54 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
252 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 14.4 • n=93 Participants
|
34.6 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
23.8 years
STANDARD_DEVIATION 10.8 • n=27 Participants
|
34.5 years
STANDARD_DEVIATION 10.0 • n=483 Participants
|
31.8 years
STANDARD_DEVIATION 10.9 • n=36 Participants
|
34.6 years
STANDARD_DEVIATION 10.0 • n=10 Participants
|
34.9 years
STANDARD_DEVIATION 9.9 • n=115 Participants
|
34.5 years
STANDARD_DEVIATION 10.0 • n=40 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
19 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
84 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
35 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
168 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Malinke
|
3 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
48 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
215 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Bozo
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Bambara
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
11 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Bobo
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Minianka
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Peulh
|
0 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
17 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Sarakole
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Sonrhai
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
Mali
|
4 participants
n=93 Participants
|
90 participants
n=4 Participants
|
4 participants
n=27 Participants
|
60 participants
n=483 Participants
|
4 participants
n=36 Participants
|
54 participants
n=10 Participants
|
36 participants
n=115 Participants
|
252 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 7 -12 days post-inoculationCount of participants with positive sensitive blood smear (sBS) occurring after PfSPZ-CVac immunization starting on day 7 post DVI. Only pilot phase arms (Arms 1a, 2a) were analyzed for this outcome measure. Arms 5a and 6a were not performed, as no patent parasitemia was observed in either Arms 1a or 2a, per the protocol.
Outcome measures
| Measure |
1a - Pilot/Safety: Dosing Interval on Days: 1
n=4 Participants
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ
|
2a - Pilot/Safety: Dosing Interval on Days: 1
n=4 Participants
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ
|
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
|---|---|---|---|---|
|
Number of Participants With Positive Sensitive Blood Smear (sBS)
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From day of inoculation to 14 days post-inoculationCount of participants with local and systemic grade 3 signs or symptoms lasting more than 48 hours despite adequate management and serious adverse events (SAEs) occurring after PfSPZ-CVac DVI. Only arm 3a was analyzed for this outcome measure, per the protocol objectives.
Outcome measures
| Measure |
1a - Pilot/Safety: Dosing Interval on Days: 1
n=4 Participants
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ
|
2a - Pilot/Safety: Dosing Interval on Days: 1
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ
|
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
|---|---|---|---|---|
|
Number of Participants With Local and Systemic Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: For the main phase: from the day of inoculation to approximately 6 months post-3rd inoculation. For the booster phase: from the time of inoculation to approximately 6 months post-booster inoculationCount of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs) occurring after PfSPZ-CVac immunization. This outcome measure applies to main phase arms 1b, 2b, 4a, and 4b. Arms 5b and 6b were not performed as patent parasitemia with the higher dose of PfSPZ was not observed in the pilot phase (Arms 1a, 2a).
Outcome measures
| Measure |
1a - Pilot/Safety: Dosing Interval on Days: 1
n=90 Participants
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ
|
2a - Pilot/Safety: Dosing Interval on Days: 1
n=60 Participants
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ
|
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57
n=54 Participants
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57
n=36 Participants
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)
|
88 Participants
|
59 Participants
|
51 Participants
|
36 Participants
|
Adverse Events
1a - Pilot/Safety: Dosing Interval on Days: 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
Serious events: 1 serious events
Other events: 88 other events
Deaths: 1 deaths
2a - Pilot/Safety: Dosing Interval on Days: 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
3a - Pilot/Safety: Dosing Interval on Days: 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1a - Pilot/Safety: Dosing Interval on Days: 1
n=4 participants at risk
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ
|
1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
n=90 participants at risk
Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
2a - Pilot/Safety: Dosing Interval on Days: 1
n=4 participants at risk
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ
|
2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
n=60 participants at risk
Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
3a - Pilot/Safety: Dosing Interval on Days: 1
n=4 participants at risk
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with chloroquine 2 days prior \& 5 days post PfSPZ
|
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57
n=54 participants at risk
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57
n=36 participants at risk
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
Other adverse events
| Measure |
1a - Pilot/Safety: Dosing Interval on Days: 1
n=4 participants at risk
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ
|
1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
n=90 participants at risk
Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
2a - Pilot/Safety: Dosing Interval on Days: 1
n=4 participants at risk
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ
|
2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57
n=60 participants at risk
Participants received 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
3a - Pilot/Safety: Dosing Interval on Days: 1
n=4 participants at risk
Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with chloroquine 2 days prior \& 5 days post PfSPZ
|
4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57
n=54 participants at risk
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ on day 1, day 29 and day 57.
|
4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57
n=36 participants at risk
Participants received normal saline (NS) via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ on day 1, day 29 and day 57.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
8.3%
3/36 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Abscess
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
4.4%
4/90 • Number of events 5 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
3/54 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
3/90 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.2%
2/90 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
4.4%
4/90 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
13.3%
8/60 • Number of events 8 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
11.1%
4/36 • Number of events 5 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
42.2%
38/90 • Number of events 83 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
25.0%
1/4 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
45.0%
27/60 • Number of events 55 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
31.5%
17/54 • Number of events 30 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
47.2%
17/36 • Number of events 27 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
7.8%
7/90 • Number of events 7 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
2/60 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
13.0%
7/54 • Number of events 9 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
2/36 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Candidiasis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
General disorders
Chills
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
10.0%
9/90 • Number of events 9 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
11.7%
7/60 • Number of events 7 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
25.9%
14/54 • Number of events 15 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
22.2%
8/36 • Number of events 8 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
8.9%
8/90 • Number of events 8 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.0%
3/60 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
7.4%
4/54 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
25.0%
1/4 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
2/36 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
16.7%
15/90 • Number of events 18 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
13.3%
8/60 • Number of events 11 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
25.0%
1/4 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
29.6%
16/54 • Number of events 17 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
8.3%
3/36 • Number of events 8 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
2/60 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
2/60 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
8.3%
3/36 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Dysentery
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.2%
2/90 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
8.3%
3/36 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Injury, poisoning and procedural complications
Eye burns
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.2%
2/90 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
General disorders
Fatigue
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
3/90 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
2/36 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Gastritis
|
25.0%
1/4 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
11.1%
10/90 • Number of events 12 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
11.7%
7/60 • Number of events 8 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
16.7%
9/54 • Number of events 13 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
11.1%
4/36 • Number of events 7 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
4.4%
4/90 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.0%
3/60 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
7.4%
4/54 • Number of events 5 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
16.7%
6/36 • Number of events 6 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Genital infection
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
6.7%
6/90 • Number of events 6 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
6.7%
4/60 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Genitourinary tract infection
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
2/60 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
30.0%
27/90 • Number of events 36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
40.0%
24/60 • Number of events 34 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
44.4%
24/54 • Number of events 37 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
52.8%
19/36 • Number of events 30 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
2/36 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
3/90 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
2/60 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
7.8%
7/90 • Number of events 8 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.0%
3/60 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
7.4%
4/54 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
General disorders
Injection site oedema
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
General disorders
Injection site pain
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
3/90 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
2/36 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.0%
3/60 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.2%
2/90 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
44.4%
40/90 • Number of events 85 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
40.0%
24/60 • Number of events 50 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
22.2%
12/54 • Number of events 23 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
36.1%
13/36 • Number of events 31 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
3/90 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
2/60 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
General disorders
Malaise
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Malaria
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
33.3%
30/90 • Number of events 40 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
40.0%
24/60 • Number of events 31 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
59.3%
32/54 • Number of events 42 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
52.8%
19/36 • Number of events 26 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
4.4%
4/90 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
6.7%
4/60 • Number of events 5 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.2%
2/90 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
3/90 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
2/60 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
2/36 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
40.0%
36/90 • Number of events 71 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
23.3%
14/60 • Number of events 32 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
20.4%
11/54 • Number of events 21 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
30.6%
11/36 • Number of events 26 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.2%
2/90 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
8.3%
5/60 • Number of events 5 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
3/54 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
13.9%
5/36 • Number of events 7 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Otitis media
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.2%
2/90 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
General disorders
Pain
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
11.1%
10/90 • Number of events 12 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
8.3%
5/60 • Number of events 8 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
7.4%
4/54 • Number of events 5 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
8.3%
3/36 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
3/90 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
4.4%
4/90 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
7.4%
4/54 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
8.3%
3/36 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Pyoderma
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
General disorders
Pyrexia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.2%
2/90 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
6.7%
4/60 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
2/36 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
53.3%
48/90 • Number of events 92 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
63.3%
38/60 • Number of events 68 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
25.0%
1/4 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
50.0%
27/54 • Number of events 47 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
61.1%
22/36 • Number of events 42 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
10.0%
9/90 • Number of events 9 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
11.7%
7/60 • Number of events 7 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
16.7%
9/54 • Number of events 12 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
11.1%
4/36 • Number of events 4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
4.4%
4/90 • Number of events 5 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
3/90 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.0%
3/60 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
3/54 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
5.6%
5/90 • Number of events 5 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
10.0%
6/60 • Number of events 6 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.2%
2/90 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.3%
2/60 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 3 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Varicella
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.2%
2/90 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.9%
1/54 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/60 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/36 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.1%
1/90 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
25.0%
1/4 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
3.7%
2/54 • Number of events 2 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
12.2%
11/90 • Number of events 11 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
15.0%
9/60 • Number of events 12 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
16.7%
9/54 • Number of events 11 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
11.1%
4/36 • Number of events 6 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/90 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
1.7%
1/60 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/4 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
0.00%
0/54 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
2.8%
1/36 • Number of events 1 • One month for pilot phase; eight months for main phase; seven months for booster phase
|
Additional Information
Dr. Dave Cook
Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 240.627.3066
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place