Trial Outcomes & Findings for Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults (NCT NCT00746798)
NCT ID: NCT00746798
Last Updated: 2015-04-03
Results Overview
Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
479 participants
Primary outcome timeframe
Day 0 and Day 28 post-vaccination
Results posted on
2015-04-03
Participant Flow
Participants were enrolled from 03 October 2008 to 08 December 2008 in 15 clinical centers in the US.
A total of 498 of the 479 randomized participants who met the inclusion and exclusion criteria were vaccinated. 1 subject was withdrawn from the study before receiving any study vaccine and was excluded from analysis and this report.
Participant milestones
| Measure |
ChimeriVax WN02 Vaccine Low Dose
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine Medium Dose
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine High Dose
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
|
Placebo
Participants who received placebo (saline) given one time subcutaneously
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
122
|
124
|
113
|
120
|
|
Overall Study
COMPLETED
|
121
|
122
|
110
|
120
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
0
|
Reasons for withdrawal
| Measure |
ChimeriVax WN02 Vaccine Low Dose
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine Medium Dose
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine High Dose
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
|
Placebo
Participants who received placebo (saline) given one time subcutaneously
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
2
|
0
|
|
Overall Study
Participant unable to return for visit
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
ChimeriVax WN02 Vaccine Low Dose
n=122 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine Medium Dose
n=124 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine High Dose
n=113 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
|
Placebo
n=120 Participants
Participants who received placebo (saline) given one time subcutaneously
|
Total
n=479 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
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
285 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
194 Participants
n=21 Participants
|
|
Age, Continuous
|
63.1 Years
STANDARD_DEVIATION 9.39 • n=5 Participants
|
62.9 Years
STANDARD_DEVIATION 8.10 • n=7 Participants
|
63.4 Years
STANDARD_DEVIATION 9.01 • n=5 Participants
|
62.2 Years
STANDARD_DEVIATION 8.28 • n=4 Participants
|
62.9 Years
STANDARD_DEVIATION 8.69 • n=21 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
268 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
211 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
122 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
479 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 post-vaccinationPopulation: Serum antibody levels were assessed in the per-protocol population.
Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.
Outcome measures
| Measure |
ChimeriVax WN02 Vaccine Low Dose
n=114 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine Medium Dose
n=118 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine High Dose
n=108 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
|
Placebo
n=114 Participants
Participants who received placebo (saline) given one time subcutaneously
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine
Day 0
|
5.00 Titers
Interval 5.0 to 5.0
|
5.76 Titers
Interval 4.92 to 6.74
|
5.06 Titers
Interval 4.94 to 5.2
|
5.22 Titers
Interval 4.8 to 5.68
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine
Day 28
|
688 Titers
Interval 453.0 to 1047.0
|
600 Titers
Interval 405.0 to 890.0
|
674 Titers
Interval 464.0 to 978.0
|
5.93 Titers
Interval 4.96 to 7.08
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 post-vaccinationPopulation: Serum antibody levels and seroconversion were assessed in the per-protocol population.
Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test. Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10.
Outcome measures
| Measure |
ChimeriVax WN02 Vaccine Low Dose
n=114 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine Medium Dose
n=118 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine High Dose
n=108 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
|
Placebo
n=114 Participants
Participants who received placebo (saline) given one time subcutaneously
|
|---|---|---|---|---|
|
Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
|
105 Participants
|
110 Participants
|
103 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 14 post-vaccinationPopulation: Safety assessments were on the Safety, intend-to-treat Population.
Outcome measures
| Measure |
ChimeriVax WN02 Vaccine Low Dose
n=122 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine Medium Dose
n=124 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine High Dose
n=112 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
|
Placebo
n=120 Participants
Participants who received placebo (saline) given one time subcutaneously
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Grade 3 Malaise (Prevents daily activities)
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Any Pain [N = 122, 123, 112, 120]
|
14 Participants
|
29 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Grade 3 Pain (Prevents daily activities)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Any Erythema [N = 122, 123, 112, 120]
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Grade 3 Erythema (> 10 cm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Any Swelling [N = 121, 123, 112, 120]
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Grade 3 Swelling (> 10 cm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Any Fever [N = 122, 123, 111, 120]
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Any Headache [N = 122, 123, 112, 120]
|
31 Participants
|
34 Participants
|
33 Participants
|
31 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Grade 3 Headache (prevents daily activities)
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Any Malaise [N = 122, 123, 112, 120]
|
26 Participants
|
26 Participants
|
27 Participants
|
25 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Any Myalgia [N = 122, 123, 112, 120]
|
28 Participants
|
25 Participants
|
22 Participants
|
20 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Grade 3 Myalgia (Prevents daily activities)
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2 up to Day 14 post-vaccinationPopulation: Viremia concentrations were assessed in a randomly selected subset of the per-protocol population.
Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units \[pfu\]/mL) viremia at the reported visit.
Outcome measures
| Measure |
ChimeriVax WN02 Vaccine Low Dose
n=80 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine Medium Dose
n=82 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine High Dose
n=73 Participants
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
|
Placebo
n=80 Participants
Participants who received placebo (saline) given one time subcutaneously
|
|---|---|---|---|---|
|
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Day 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Day 4
|
33 Participants
|
28 Participants
|
15 Participants
|
0 Participants
|
|
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Day 6
|
21 Participants
|
33 Participants
|
29 Participants
|
0 Participants
|
|
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Day 8
|
19 Participants
|
19 Participants
|
21 Participants
|
0 Participants
|
|
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Day 10
|
15 Participants
|
18 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Day 12
|
7 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Day 14
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
ChimeriVax WN02 Vaccine Low Dose
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
ChimeriVax WN02 Vaccine Medium Dose
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
ChimeriVax WN02 Vaccine High Dose
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ChimeriVax WN02 Vaccine Low Dose
n=122 participants at risk
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine Medium Dose
n=124 participants at risk
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine High Dose
n=112 participants at risk
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
|
Placebo
n=120 participants at risk
Participants who received placebo (saline) given one time subcutaneously
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/112 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.83%
1/120 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Cardiac disorders
Atrial fibrillation
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.89%
1/112 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/120 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.81%
1/124 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/112 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/120 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/112 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.83%
1/120 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Congenital, familial and genetic disorders
Vitello intestinal duct remnant
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/112 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.83%
1/120 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Infections and infestations
Influenza
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/112 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
1.7%
2/120 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Infections and infestations
Pneumonia
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/112 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
—
0/0 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Accidential poisoning
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.89%
1/112 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/120 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/112 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/120 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.89%
1/112 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/120 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/112 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.83%
1/120 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage II
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/112 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/120 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.89%
1/112 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/120 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial aneurysm
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/124 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/112 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.00%
0/120 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
Other adverse events
| Measure |
ChimeriVax WN02 Vaccine Low Dose
n=122 participants at risk
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine Medium Dose
n=124 participants at risk
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
|
ChimeriVax WN02 Vaccine High Dose
n=112 participants at risk
Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
|
Placebo
n=120 participants at risk
Participants who received placebo (saline) given one time subcutaneously
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.3%
4/122 • Number of events 5 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
4.8%
6/124 • Number of events 6 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
5.4%
6/112 • Number of events 6 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
6.7%
8/120 • Number of events 10 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
4/122 • Number of events 5 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
0.81%
1/124 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
1.8%
2/112 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
6.7%
8/120 • Number of events 9 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
7/122 • Number of events 7 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
2.4%
3/124 • Number of events 4 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
2.7%
3/112 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
5.8%
7/120 • Number of events 8 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
General disorders
Injection site pain
|
11.5%
14/122 • Number of events 14 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
23.4%
29/124 • Number of events 29 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
8.9%
10/112 • Number of events 10 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
10.0%
12/120 • Number of events 12 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Nervous system disorders
Headache
|
25.4%
31/122 • Number of events 31 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
27.4%
34/124 • Number of events 34 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
29.5%
33/112 • Number of events 33 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
25.8%
31/120 • Number of events 31 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
General disorders
Malaise
|
21.3%
26/122 • Number of events 26 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
21.0%
26/124 • Number of events 26 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
24.1%
27/112 • Number of events 27 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
20.8%
25/120 • Number of events 25 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.0%
28/122 • Number of events 28 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
20.2%
25/124 • Number of events 25 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
19.6%
22/112 • Number of events 22 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
|
16.7%
20/120 • Number of events 20 • Adverse events data were collected from the day of vaccination (Day 0) 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