Trial Outcomes & Findings for Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults (NCT NCT00442169)
NCT ID: NCT00442169
Last Updated: 2016-04-14
Results Overview
Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
208 participants
Primary outcome timeframe
Day 28 post-vaccination
Results posted on
2016-04-14
Participant Flow
Participants were enrolled from 09 December 2005 to 27 March 2006 in 5 clinical centers in the US.
A total of 208 participants (Part 1 = 112; Part 2 = 96) who met the inclusion and exclusion criteria were enrolled, randomized, and vaccinated in the study. Report on Part 1 and Part 2 participants with valid data are presented in this report.
Participant milestones
| Measure |
Placebo (Part 1)
Participants in Part 1 of the study who received a single dose of saline on Day 0
|
WN02 Low Dose (Part 1)
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
|
WN02 Medium Dose (Part 1)
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
WN02 High Dose (Part 1)
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
Placebo (Part 2)
Participants in Part 2 of the study who received a placebo vaccine on Day 0
|
WNO2 High Dose (Part 2)
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
17
|
24
|
40
|
31
|
0
|
0
|
|
Part 1
COMPLETED
|
17
|
24
|
40
|
31
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
0
|
25
|
57
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
25
|
57
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
Placebo (Part 1)
n=17 Participants
Participants in Part 1 of the study who received a single dose of saline on Day 0
|
WN02 Low Dose (Part 1)
n=24 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
|
WN02 Medium Dose (Part 1)
n=40 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
WN02 High Dose (Part 1)
n=31 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
Placebo (Part 2)
n=25 Participants
Participants in Part 2 of the study who received a placebo vaccine on Day 0
|
WNO2 High Dose (Part 2)
n=57 Participants
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
Total
n=194 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
152 Participants
n=8 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
|
14 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
|
Age, Continuous
|
26.6 Years
STANDARD_DEVIATION 6.41 • n=5 Participants
|
25.4 Years
STANDARD_DEVIATION 5.62 • n=7 Participants
|
25 Years
STANDARD_DEVIATION 5.43 • n=5 Participants
|
25.1 Years
STANDARD_DEVIATION 6.47 • n=4 Participants
|
61.4 Years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
61.0 Years
STANDARD_DEVIATION 11.3 • n=8 Participants
|
25.7 Years
STANDARD_DEVIATION 6.13 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
114 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
80 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
57 Participants
n=8 Participants
|
194 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Seroconversion was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population
Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples
Outcome measures
| Measure |
Placebo (Part 1)
n=17 Participants
Participants in Part 1 of the study who received a single dose of saline on Day 0
|
WN02 Low Dose (Part 1)
n=21 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
|
WN02 Medium Dose (Part 1)
n=37 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
WN02 High Dose (Part 1)
n=28 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
Placebo (Part 2)
n=25 Participants
Participants in Part 2 of the study who received a placebo vaccine on Day 0
|
WNO2 High Dose (Part 2)
n=55 Participants
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
|---|---|---|---|---|---|---|
|
Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion).
|
0 Participants
|
21 Participants
|
36 Participants
|
27 Participants
|
0 Participants
|
53 Participants
|
PRIMARY outcome
Timeframe: Day 21 post-vaccinationPopulation: Viremia was assessed in all participants in the safety population according to the vaccine actually received.
Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL
Outcome measures
| Measure |
Placebo (Part 1)
n=17 Participants
Participants in Part 1 of the study who received a single dose of saline on Day 0
|
WN02 Low Dose (Part 1)
n=24 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
|
WN02 Medium Dose (Part 1)
n=40 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
WN02 High Dose (Part 1)
n=31 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
Placebo (Part 2)
n=32 Participants
Participants in Part 2 of the study who received a placebo vaccine on Day 0
|
WNO2 High Dose (Part 2)
n=64 Participants
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
|---|---|---|---|---|---|---|
|
Number of Viremic Participants Post-vaccination
|
2 Participants
|
22 Participants
|
36 Participants
|
29 Participants
|
1 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: Days 0 to 28 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants according to the vaccine actually received, safety population.
Outcome measures
| Measure |
Placebo (Part 1)
n=17 Participants
Participants in Part 1 of the study who received a single dose of saline on Day 0
|
WN02 Low Dose (Part 1)
n=24 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
|
WN02 Medium Dose (Part 1)
n=40 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
WN02 High Dose (Part 1)
n=31 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
Placebo (Part 2)
n=32 Participants
Participants in Part 2 of the study who received a placebo vaccine on Day 0
|
WNO2 High Dose (Part 2)
n=64 Participants
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
|---|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Fatigue
|
4 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Headache
|
5 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Malaise
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Feeling Hot
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Myalgia
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
13 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Arthralgia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Chills
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Dizziness
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Musculoskeletal stiffness
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Injection site pain
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Nausea
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Somnolence
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Diarrhoea
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Pharyngolaryngeal pain
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Injection site erythema
|
NA Participants
Not collected in Part 1
|
NA Participants
Not collected in Part 1
|
NA Participants
Not collected in Part 1
|
NA Participants
Not collected in Part 1
|
6 Participants
|
9 Participants
|
|
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.
Injection site induration
|
NA Participants
Not collected in Part 1
|
NA Participants
Not collected in Part 1
|
NA Participants
Not collected in Part 1
|
NA Participants
Not collected in Part 1
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Days 0, 14, and 28 post-vaccinationPopulation: Geometric mean titers were assessed according to the vaccine actually received, in the As treat per-protocol population.
Outcome measures
| Measure |
Placebo (Part 1)
n=17 Participants
Participants in Part 1 of the study who received a single dose of saline on Day 0
|
WN02 Low Dose (Part 1)
n=21 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
|
WN02 Medium Dose (Part 1)
n=37 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
WN02 High Dose (Part 1)
n=28 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
Placebo (Part 2)
n=32 Participants
Participants in Part 2 of the study who received a placebo vaccine on Day 0
|
WNO2 High Dose (Part 2)
n=64 Participants
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.
Day 0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
5.0 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.
Day 14
|
5.0 Titers
Interval 5.0 to 5.0
|
16.8 Titers
Interval 7.2 to 39.5
|
35.7 Titers
Interval 18.3 to 69.7
|
26.9 Titers
Interval 11.8 to 61.5
|
5.0 Titers
Interval 5.0 to 5.0
|
19.2 Titers
Interval 11.9 to 31.2
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.
Day 28
|
5.0 Titers
Interval 5.0 to 5.0
|
1367.3 Titers
Interval 711.3 to 2628.5
|
2331.1 Titers
Interval 1193.3 to 4554.3
|
3309.3 Titers
Interval 1726.9 to 6341.7
|
5.0 Titers
Interval 5.0 to 5.0
|
922.4 Titers
Interval 519.2 to 1638.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 14 and 28 post-vaccinationPopulation: Immunoglobulin M (IgM) response was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population
Outcome measures
| Measure |
Placebo (Part 1)
n=17 Participants
Participants in Part 1 of the study who received a single dose of saline on Day 0
|
WN02 Low Dose (Part 1)
n=21 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
|
WN02 Medium Dose (Part 1)
n=37 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
WN02 High Dose (Part 1)
n=28 Participants
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
Placebo (Part 2)
n=25 Participants
Participants in Part 2 of the study who received a placebo vaccine on Day 0
|
WNO2 High Dose (Part 2)
n=56 Participants
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population
IgM Positive at Day 14
|
0 Participants
|
5 Participants
|
22 Participants
|
10 Participants
|
0 Participants
|
26 Participants
|
|
Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population
IgM Positive at Day 28
|
0 Participants
|
20 Participants
|
36 Participants
|
27 Participants
|
0 Participants
|
53 Participants
|
Adverse Events
Placebo (Part 1)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
WN02 Low Dose (Part 1)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
WN02 Medium Dose (Part 1)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
WN02 High Dose (Part 1)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo (Part 2)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
WNO2 High Dose (Part 2)
Serious events: 3 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part 1)
n=17 participants at risk
Participants in Part 1 of the study who received a single dose of saline on Day 0
|
WN02 Low Dose (Part 1)
n=24 participants at risk
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
|
WN02 Medium Dose (Part 1)
n=40 participants at risk
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
WN02 High Dose (Part 1)
n=31 participants at risk
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
Placebo (Part 2)
n=32 participants at risk
Participants in Part 2 of the study who received a placebo vaccine on Day 0
|
WNO2 High Dose (Part 2)
n=64 participants at risk
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/64 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive plumonary disease
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
1.6%
1/64 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
1.6%
1/64 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
1.6%
1/64 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
1.6%
1/64 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
1.6%
1/64 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
Other adverse events
| Measure |
Placebo (Part 1)
n=17 participants at risk
Participants in Part 1 of the study who received a single dose of saline on Day 0
|
WN02 Low Dose (Part 1)
n=24 participants at risk
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
|
WN02 Medium Dose (Part 1)
n=40 participants at risk
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
WN02 High Dose (Part 1)
n=31 participants at risk
Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
Placebo (Part 2)
n=32 participants at risk
Participants in Part 2 of the study who received a placebo vaccine on Day 0
|
WNO2 High Dose (Part 2)
n=64 participants at risk
Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
16.7%
4/24 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
5.0%
2/40 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.5%
2/31 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
9.4%
3/32 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
10.9%
7/64 • Number of events 7 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
8.3%
2/24 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
10.0%
4/40 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
9.7%
3/31 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.2%
2/32 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
10.9%
7/64 • Number of events 7 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
General disorders
Chills
|
5.9%
1/17 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
4.2%
1/24 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.5%
3/40 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.5%
2/31 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.8%
5/64 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
General disorders
Fatigue
|
23.5%
4/17 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
8.3%
2/24 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
27.5%
11/40 • Number of events 11 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
12.9%
4/31 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
21.9%
7/32 • Number of events 7 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
21.9%
14/64 • Number of events 14 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
General disorders
Feeling Hot
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
4.2%
1/24 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
10.0%
4/40 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
9.7%
3/31 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.8%
5/64 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
General disorders
Malaise
|
17.6%
3/17 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
4.2%
1/24 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
17.5%
7/40 • Number of events 7 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
12.9%
4/31 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
18.8%
6/32 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
21.9%
14/64 • Number of events 14 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
10.0%
4/40 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
1.6%
1/64 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.5%
3/40 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
2/64 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
17.6%
3/17 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
12.5%
3/24 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
9.7%
3/31 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
1.6%
1/64 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Investigations
White Blood Cell Count Decreased
|
5.9%
1/17 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
12.5%
3/24 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.5%
3/40 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
12.9%
4/31 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
2/64 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Investigations
White Blood Cell Count Increased
|
5.9%
1/17 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.5%
3/40 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
2/64 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
4.2%
1/24 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.5%
3/40 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
15.6%
5/32 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
17.2%
11/64 • Number of events 11 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.5%
2/31 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
12.5%
4/32 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
4.7%
3/64 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
5.9%
1/17 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
8.3%
2/24 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
5.0%
2/40 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
15.6%
5/32 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
12.5%
8/64 • Number of events 8 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.6%
3/17 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
8.3%
2/24 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
15.0%
6/40 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
15.6%
5/32 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
29.7%
19/64 • Number of events 19 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.9%
1/17 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
5.0%
2/40 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.5%
2/31 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
1.6%
1/64 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
8.3%
2/24 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
10.0%
4/40 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.8%
5/64 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Nervous system disorders
Headache
|
41.2%
7/17 • Number of events 17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
37.5%
9/24 • Number of events 9 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
35.0%
14/40 • Number of events 14 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
25.8%
8/31 • Number of events 8 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
28.1%
9/32 • Number of events 9 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
28.1%
18/64 • Number of events 18 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
4.2%
1/24 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
5.0%
2/40 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
9.7%
3/31 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.2%
2/32 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
9.4%
6/64 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
4.2%
1/24 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.5%
2/31 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
2/64 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
2.5%
1/40 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
9.7%
3/31 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.2%
2/32 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
1.6%
1/64 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
17.6%
3/17 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
8.3%
2/24 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
10.0%
4/40 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
9.7%
3/31 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
12.5%
4/32 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.8%
5/64 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
4.2%
1/24 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
2.5%
1/40 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.8%
5/64 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
2.5%
1/40 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.1%
1/32 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
7.8%
5/64 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.2%
4/64 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
2.5%
1/40 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.2%
4/64 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/32 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.2%
4/64 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
General disorders
Injection site erythema
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
18.8%
6/32 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
14.1%
9/64 • Number of events 9 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
General disorders
Injection site induration
|
0.00%
0/17 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/40 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
18.8%
6/32 • Number of events 6 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.2%
4/64 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
|
General disorders
Injection site pain
|
11.8%
2/17 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/24 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
2.5%
1/40 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
0.00%
0/31 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
15.6%
5/32 • Number of events 5 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
6.2%
4/64 • Number of events 4 • Adverse events data were collected from the day of vaccination to up to 6 months, post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER