Trial Outcomes & Findings for Study of the Transmission-Blocking Vaccine Pfs230D1-EPA/Matrix-M Against Malaria in Adults in Mali (NCT NCT05135273)
NCT ID: NCT05135273
Last Updated: 2024-05-06
Results Overview
The analyses included only subjects who received at least one vaccination
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
Results posted on
2024-05-06
Participant Flow
Participant milestones
| Measure |
12.5 µg Dose (Arm 1a Pilot)
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 1b Pilot)
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 1c Pilot)
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 1d Pilot)
Participants received 3 doses of rabies vaccine (standard dose)
Pilot/safety: Dosing interval on days: 1, 29, 57
|
12.5 µg (Arm 2a Main)
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 2b Main)
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 2c Main)
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 2d Main)
Participants received 3 doses of rabies vaccine (standard dose)
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
4
|
14
|
14
|
15
|
16
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
4
|
13
|
13
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
12.5 µg Dose (Arm 1a Pilot)
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 1b Pilot)
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 1c Pilot)
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 1d Pilot)
Participants received 3 doses of rabies vaccine (standard dose)
Pilot/safety: Dosing interval on days: 1, 29, 57
|
12.5 µg (Arm 2a Main)
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 2b Main)
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 2c Main)
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 2d Main)
Participants received 3 doses of rabies vaccine (standard dose)
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Recruited into the army
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Moved away from study site
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Travel
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of the Transmission-Blocking Vaccine Pfs230D1-EPA/Matrix-M Against Malaria in Adults in Mali
Baseline characteristics by cohort
| Measure |
12.5 µg Dose (Arm 1a Pilot)
n=5 Participants
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 1b Pilot)
n=5 Participants
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 1c Pilot)
n=5 Participants
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 1d Pilot)
n=4 Participants
Participants received 3 doses of rabies vaccine (standard dose)
Pilot/safety: Dosing interval on days: 1, 29, 57
|
12.5 µg (Arm 2a Main)
n=14 Participants
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 2b Main)
n=14 Participants
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 2c Main)
n=15 Participants
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 2d Main)
n=16 Participants
Participants received 3 doses of rabies vaccine (standard dose)
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
78 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
29 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
49 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
78 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Mali
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
14 participants
n=21 Participants
|
14 participants
n=10 Participants
|
15 participants
n=115 Participants
|
16 participants
n=6 Participants
|
78 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 monthsThe analyses included only subjects who received at least one vaccination
Outcome measures
| Measure |
12.5 µg Dose (Arm 1a Pilot)
n=5 Participants
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 1b Pilot)
n=5 Participants
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 1c Pilot)
n=5 Participants
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 1d Pilot)
n=4 Participants
Participants received 3 doses of rabies vaccine (standard dose)
Pilot/safety: Dosing interval on days: 1, 29, 57
|
12.5 µg (Arm 2a Main)
n=14 Participants
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 2b Main)
n=14 Participants
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 2c Main)
n=15 Participants
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 2d Main)
n=16 Participants
Participants received 3 doses of rabies vaccine (standard dose)
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
|---|---|---|---|---|---|---|---|---|
|
Number of Local and Systemic Adverse Events (AEs) to Assess the Safety of the Study Drug
|
34 Adverse Events
|
24 Adverse Events
|
23 Adverse Events
|
16 Adverse Events
|
45 Adverse Events
|
60 Adverse Events
|
58 Adverse Events
|
39 Adverse Events
|
PRIMARY outcome
Timeframe: Serious Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 monthsOutcome measures
| Measure |
12.5 µg Dose (Arm 1a Pilot)
n=5 Participants
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 1b Pilot)
n=5 Participants
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 1c Pilot)
n=5 Participants
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 1d Pilot)
n=4 Participants
Participants received 3 doses of rabies vaccine (standard dose)
Pilot/safety: Dosing interval on days: 1, 29, 57
|
12.5 µg (Arm 2a Main)
n=14 Participants
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 2b Main)
n=14 Participants
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 2c Main)
n=15 Participants
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 2d Main)
n=16 Participants
Participants received 3 doses of rabies vaccine (standard dose)
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
|---|---|---|---|---|---|---|---|---|
|
Number of Local and Systemic Serious Adverse Events (SAEs) to Assess the Safety of the Study Drug
|
1 Serious Adverse Events
|
0 Serious Adverse Events
|
0 Serious Adverse Events
|
0 Serious Adverse Events
|
0 Serious Adverse Events
|
0 Serious Adverse Events
|
0 Serious Adverse Events
|
0 Serious Adverse Events
|
Adverse Events
12.5 µg Dose (Arm 1a Pilot)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
20 µg Dose (Arm 1b Pilot)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
40 µg Dose (Arm 1c Pilot)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Rabies Comparator (Arm 1d Pilot)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
12.5 µg (Arm 2a Main)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
20 µg Dose (Arm 2b Main)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
40 µg Dose (Arm 2c Main)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Rabies Comparator (Arm 2d Main)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
12.5 µg Dose (Arm 1a Pilot)
n=5 participants at risk
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 1b Pilot)
n=5 participants at risk
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 1c Pilot)
n=5 participants at risk
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 1d Pilot)
n=4 participants at risk
Participants received 3 doses of rabies vaccine (standard dose)
Pilot/safety: Dosing interval on days: 1, 29, 57
|
12.5 µg (Arm 2a Main)
n=14 participants at risk
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 2b Main)
n=14 participants at risk
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 2c Main)
n=15 participants at risk
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 2d Main)
n=16 participants at risk
Participants received 3 doses of rabies vaccine (standard dose)
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
Other adverse events
| Measure |
12.5 µg Dose (Arm 1a Pilot)
n=5 participants at risk
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 1b Pilot)
n=5 participants at risk
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 1c Pilot)
n=5 participants at risk
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Pilot/safety: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 1d Pilot)
n=4 participants at risk
Participants received 3 doses of rabies vaccine (standard dose)
Pilot/safety: Dosing interval on days: 1, 29, 57
|
12.5 µg (Arm 2a Main)
n=14 participants at risk
Participants received 3 doses of 12.5 µg Pfs230D1-EPA/25 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
20 µg Dose (Arm 2b Main)
n=14 participants at risk
Participants received 3 doses of 20 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
40 µg Dose (Arm 2c Main)
n=15 participants at risk
Participants received 3 doses of 40 µg Pfs230D1-EPA/50 µg Matrix-M
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
Rabies Comparator (Arm 2d Main)
n=16 participants at risk
Participants received 3 doses of rabies vaccine (standard dose)
Main/Safety/efficacy: Dosing interval on days: 1, 29, 57
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
25.0%
1/4 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
14.3%
2/14 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.7%
1/15 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.7%
1/15 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Blood and lymphatic system disorders
Blood creatinine increased
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.7%
1/15 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.2%
1/16 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Reproductive system and breast disorders
Candidiasis
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.2%
1/16 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Eye disorders
Cataract
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
13.3%
2/15 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.2%
1/16 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Gastrointestinal disorders
Decreased appetite
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.7%
1/15 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Ear and labyrinth disorders
Dizziness
|
40.0%
2/5 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Gastrointestinal disorders
Dysentery
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.7%
1/15 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.7%
1/15 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
General disorders
Fatigue
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
14.3%
2/14 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.7%
1/15 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
40.0%
2/5 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
13.3%
2/15 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.2%
1/16 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
General disorders
Headache
|
60.0%
3/5 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
60.0%
3/5 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
28.6%
4/14 • Number of events 6 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
21.4%
3/14 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
66.7%
10/15 • Number of events 16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
25.0%
4/16 • Number of events 5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Musculoskeletal and connective tissue disorders
Injection site pain
|
80.0%
4/5 • Number of events 6 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
60.0%
3/5 • Number of events 6 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
60.0%
3/5 • Number of events 6 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
50.0%
7/14 • Number of events 9 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
64.3%
9/14 • Number of events 11 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
66.7%
10/15 • Number of events 12 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.2%
1/16 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Blood and lymphatic system disorders
Leuokocytosis
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.7%
1/15 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
25.0%
1/4 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
21.4%
3/14 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
13.3%
2/15 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.2%
1/16 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
General disorders
Malaise
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Infections and infestations
Malaria
|
60.0%
3/5 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
60.0%
3/5 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
50.0%
2/4 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
28.6%
4/14 • Number of events 7 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
21.4%
3/14 • Number of events 5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
3/15 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
31.2%
5/16 • Number of events 7 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
40.0%
2/5 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
21.4%
3/14 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
13.3%
2/15 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.2%
1/16 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
12.5%
2/16 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
2/5 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
25.0%
1/4 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
35.7%
5/14 • Number of events 9 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
18.8%
3/16 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
General disorders
Pain
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.7%
1/15 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
25.0%
1/4 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
14.3%
2/14 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.2%
1/16 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
13.3%
2/15 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.2%
1/16 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
60.0%
3/5 • Number of events 5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
40.0%
2/5 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
50.0%
2/4 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
21.4%
3/14 • Number of events 3 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
64.3%
9/14 • Number of events 10 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
33.3%
5/15 • Number of events 6 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
50.0%
8/16 • Number of events 10 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinobronchitis
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
25.0%
1/4 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
21.4%
3/14 • Number of events 4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.7%
1/15 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
6.2%
1/16 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Gastrointestinal disorders
Tonsillitis
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
20.0%
1/5 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
25.0%
1/4 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
25.0%
1/4 • Number of events 2 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/5 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/4 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/14 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
7.1%
1/14 • Number of events 1 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/15 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
0.00%
0/16 • Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
|
Additional Information
Dr. David Cook
Laboratory of Malaria Immunology and Vaccinology, NIAID/NIH
Phone: 240.627.3066
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60