Trial Outcomes & Findings for Trial of an Inactivated Yellow Fever Virus Vaccine (NCT NCT05172544)
NCT ID: NCT05172544
Last Updated: 2025-09-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Day 1 post first vaccination to Day 180 post second vaccination
Results posted on
2025-09-18
Participant Flow
Participant milestones
| Measure |
Low Dose
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
6
|
|
Overall Study
COMPLETED
|
9
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Low Dose
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Trial of an Inactivated Yellow Fever Virus Vaccine
Baseline characteristics by cohort
| Measure |
Low Dose
n=10 Participants
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
n=10 Participants
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
n=6 Participants
Placebo intramuscularly (IM) on Days 1 and 29.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
34.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
6 participants
n=5 Participants
|
26 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 post first vaccination to Day 180 post second vaccinationPopulation: One placebo subject was excluded from analysis (Did not receive vaccination).
Outcome measures
| Measure |
Low Dose
n=10 Participants
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
n=10 Participants
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
n=5 Participants
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Occurrence of All Serious Adverse Events (SAEs) at Any Time During the Study
|
0 Serious Adverse Event
|
0 Serious Adverse Event
|
0 Serious Adverse Event
|
PRIMARY outcome
Timeframe: Through day 29 after the second vaccinationPopulation: One placebo subject was excluded from analysis (Did not receive vaccination).
Outcome measures
| Measure |
Low Dose
n=10 Participants
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
n=10 Participants
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
n=5 Participants
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Occurrence of All Grade 3 Unsolicited Adverse Events (AEs) From First Vaccination Through Day 29 After the Second Vaccination
Related
|
0 Grade 3 Unsolicited Adverse Event
|
0 Grade 3 Unsolicited Adverse Event
|
0 Grade 3 Unsolicited Adverse Event
|
|
Occurrence of All Grade 3 Unsolicited Adverse Events (AEs) From First Vaccination Through Day 29 After the Second Vaccination
Unrelated
|
0 Grade 3 Unsolicited Adverse Event
|
0 Grade 3 Unsolicited Adverse Event
|
0 Grade 3 Unsolicited Adverse Event
|
PRIMARY outcome
Timeframe: Through day 15 after the second vaccinationPopulation: One placebo subject was excluded from analysis (Did not receive vaccination).
Outcome measures
| Measure |
Low Dose
n=10 Participants
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
n=10 Participants
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
n=5 Participants
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Occurrence of All Grade 3 Laboratory Toxicities From First Vaccination Through Day 15 After the Second Vaccination
Related
|
0 Grade 3 Laboratory Toxicities
|
0 Grade 3 Laboratory Toxicities
|
0 Grade 3 Laboratory Toxicities
|
|
Occurrence of All Grade 3 Laboratory Toxicities From First Vaccination Through Day 15 After the Second Vaccination
Unrelated
|
0 Grade 3 Laboratory Toxicities
|
0 Grade 3 Laboratory Toxicities
|
1 Grade 3 Laboratory Toxicities
|
PRIMARY outcome
Timeframe: Through 7 days after each vaccinationPopulation: One subject in the low dose group withdrew prior to the second vaccination. One placebo subject was excluded from analysis (Did not receive vaccination).
Outcome measures
| Measure |
Low Dose
n=10 Participants
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
n=10 Participants
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
n=5 Participants
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 1, Day 3
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 1, Day 4
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 1, Day 5-7
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 2, Day 0
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 2, Day 1
|
3 Solicited Local Adverse Event
|
3 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 2, Day 2
|
1 Solicited Local Adverse Event
|
1 Solicited Local Adverse Event
|
1 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 2, Day 3
|
1 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 2, Day 4
|
1 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 2, Day 5-7
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 1, Day 0
|
0 Solicited Local Adverse Event
|
1 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 1, Day 1
|
1 Solicited Local Adverse Event
|
4 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
|
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Local Symptom, Post-Dose 1, Day 2
|
0 Solicited Local Adverse Event
|
3 Solicited Local Adverse Event
|
0 Solicited Local Adverse Event
|
PRIMARY outcome
Timeframe: Through 7 days after each vaccinationPopulation: One subject in the low dose group withdrew prior to the second vaccination. One placebo subject was excluded from analysis (Did not receive vaccination).
Outcome measures
| Measure |
Low Dose
n=10 Participants
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
n=10 Participants
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
n=5 Participants
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 1, Day 0
|
0 Solicited Systemic Adverse Event
|
1 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 1, Day 1
|
3 Solicited Systemic Adverse Event
|
1 Solicited Systemic Adverse Event
|
1 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 1, Day 2
|
1 Solicited Systemic Adverse Event
|
1 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 1, Day 3
|
0 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 1, Day 4
|
2 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 1, Day 5-7
|
2 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 2, Day 0
|
0 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 2, Day 1
|
1 Solicited Systemic Adverse Event
|
2 Solicited Systemic Adverse Event
|
1 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 2, Day 2
|
1 Solicited Systemic Adverse Event
|
2 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 2, Day 3
|
1 Solicited Systemic Adverse Event
|
1 Solicited Systemic Adverse Event
|
1 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 2, Day 4
|
0 Solicited Systemic Adverse Event
|
1 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
|
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Any Systemic Symptom, Post-Dose 2, Day 5-7
|
3 Solicited Systemic Adverse Event
|
1 Solicited Systemic Adverse Event
|
0 Solicited Systemic Adverse Event
|
PRIMARY outcome
Timeframe: Through day 29 after the second vaccinationPopulation: One placebo subject was excluded from analysis (Did not receive vaccination).
Outcome measures
| Measure |
Low Dose
n=10 Participants
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
n=10 Participants
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
n=5 Participants
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Occurrence of Any AE Through Day 29 After the Second Vaccination
At least one local solicited adverse event
|
4 Adverse Event
|
7 Adverse Event
|
1 Adverse Event
|
|
Occurrence of Any AE Through Day 29 After the Second Vaccination
At least one systemic solicited adverse event
|
6 Adverse Event
|
4 Adverse Event
|
3 Adverse Event
|
|
Occurrence of Any AE Through Day 29 After the Second Vaccination
At least one related unsolicited adverse event
|
0 Adverse Event
|
0 Adverse Event
|
0 Adverse Event
|
|
Occurrence of Any AE Through Day 29 After the Second Vaccination
At least one unrelated unsolicited adverse event
|
6 Adverse Event
|
7 Adverse Event
|
5 Adverse Event
|
SECONDARY outcome
Timeframe: At day 29 after first vaccination and at day 29 after second vaccinationPopulation: One low dose subject withdrew prior to the second vaccination.
Outcome measures
| Measure |
Low Dose
n=10 Participants
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
n=10 Participants
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
n=5 Participants
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Percentage of Subjects Achieving Seroconversion (Greater Than or Equal to 1:10 in Plaque Reduction Neutralizing Titer [PRNT50] Titer) at Day 29 After First Vaccination and at Day 29 After Second Vaccination
Day 29 Post Dose 1
|
10.0 percentage of participants
Interval 0.51 to 44.44
|
10.0 percentage of participants
Interval 0.51 to 44.44
|
0.0 percentage of participants
Interval 0.0 to 50.0
|
|
Percentage of Subjects Achieving Seroconversion (Greater Than or Equal to 1:10 in Plaque Reduction Neutralizing Titer [PRNT50] Titer) at Day 29 After First Vaccination and at Day 29 After Second Vaccination
Day 29 Post Dose 2
|
22.2 percentage of participants
Interval 4.1 to 56.0
|
20.0 percentage of participants
Interval 3.68 to 55.56
|
0.0 percentage of participants
Interval 0.0 to 50.0
|
SECONDARY outcome
Timeframe: At days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccinationPopulation: One low dose subject withdrew prior to the second vaccination.
Outcome measures
| Measure |
Low Dose
n=10 Participants
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
n=10 Participants
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
n=5 Participants
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Geometric Mean Neutralizing Titers at Days 15 and 29 After First Vaccination and at Days 15, 29, 57, and 180 Following Second Vaccination
Day 15 Post Dose 1
|
5.00 PRNT50 GMT
Interval 5.0 to 5.0
|
5.00 PRNT50 GMT
Interval 5.0 to 5.0
|
5.00 PRNT50 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Titers at Days 15 and 29 After First Vaccination and at Days 15, 29, 57, and 180 Following Second Vaccination
Day 29 Post Dose 1
|
5.74 PRNT50 GMT
Interval 4.2 to 7.86
|
5.74 PRNT50 GMT
Interval 4.2 to 7.86
|
5.00 PRNT50 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Titers at Days 15 and 29 After First Vaccination and at Days 15, 29, 57, and 180 Following Second Vaccination
Day 15 Post Dose 2
|
7.35 PRNT50 GMT
Interval 4.02 to 13.42
|
6.16 PRNT50 GMT
Interval 4.4 to 8.6
|
5.00 PRNT50 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Titers at Days 15 and 29 After First Vaccination and at Days 15, 29, 57, and 180 Following Second Vaccination
Day 29 Post Dose 2
|
7.35 PRNT50 GMT
Interval 4.02 to 13.42
|
6.60 PRNT50 GMT
Interval 4.09 to 10.65
|
5.00 PRNT50 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Titers at Days 15 and 29 After First Vaccination and at Days 15, 29, 57, and 180 Following Second Vaccination
Day 57 Post Dose 2
|
6.80 PRNT50 GMT
Interval 3.96 to 11.68
|
5.74 PRNT50 GMT
Interval 4.2 to 7.86
|
5.00 PRNT50 GMT
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Titers at Days 15 and 29 After First Vaccination and at Days 15, 29, 57, and 180 Following Second Vaccination
Day 180 Post Dose 2
|
5.83 PRNT50 GMT
Interval 4.09 to 8.32
|
5.00 PRNT50 GMT
Interval 5.0 to 5.0
|
5.00 PRNT50 GMT
Interval 5.0 to 5.0
|
Adverse Events
Low Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
High Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose
n=10 participants at risk
1 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
High Dose
n=10 participants at risk
5 mcg intramuscularly (IM) of HydroVax-002 YFV on Days 1 and 29.
|
Placebo
n=5 participants at risk
Placebo intramuscularly (IM) on Days 1 and 29.
|
|---|---|---|---|
|
Investigations
Blood pressure increased
|
0.00%
0/10 • 7 months
|
0.00%
0/10 • 7 months
|
20.0%
1/5 • Number of events 1 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
20.0%
1/5 • Number of events 1 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/5 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/10 • 7 months
|
0.00%
0/10 • 7 months
|
20.0%
1/5 • Number of events 1 • 7 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/5 • 7 months
|
|
Eye disorders
Periorbital swelling
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
0.00%
0/5 • 7 months
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
0.00%
0/5 • 7 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
0.00%
0/5 • 7 months
|
|
Gastrointestinal disorders
Lipoedema
|
0.00%
0/10 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/5 • 7 months
|
|
General disorders
Vessel puncture site bruise
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
0.00%
0/5 • 7 months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/5 • 7 months
|
|
Infections and infestations
COVID-19
|
20.0%
2/10 • Number of events 2 • 7 months
|
0.00%
0/10 • 7 months
|
60.0%
3/5 • Number of events 3 • 7 months
|
|
Infections and infestations
Otitis media
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
0.00%
0/5 • 7 months
|
|
Infections and infestations
Pyuria
|
0.00%
0/10 • 7 months
|
0.00%
0/10 • 7 months
|
20.0%
1/5 • Number of events 1 • 7 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/5 • 7 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
20.0%
1/5 • Number of events 1 • 7 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • 7 months
|
0.00%
0/10 • 7 months
|
20.0%
1/5 • Number of events 1 • 7 months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
0.00%
0/5 • 7 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/10 • 7 months
|
0.00%
0/10 • 7 months
|
20.0%
1/5 • Number of events 1 • 7 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/5 • 7 months
|
|
Injury, poisoning and procedural complications
Exposure to SARS- CoV-2
|
0.00%
0/10 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/5 • 7 months
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/10 • 7 months
|
0.00%
0/10 • 7 months
|
20.0%
1/5 • Number of events 1 • 7 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
10.0%
1/10 • Number of events 1 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/5 • 7 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/10 • 7 months
|
0.00%
0/10 • 7 months
|
20.0%
1/5 • Number of events 1 • 7 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/10 • 7 months
|
0.00%
0/5 • 7 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • 7 months
|
10.0%
1/10 • Number of events 1 • 7 months
|
0.00%
0/5 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place