Trial Outcomes & Findings for A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX (NCT NCT00319592)
NCT ID: NCT00319592
Last Updated: 2012-08-20
Results Overview
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of \< 1:10.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and up to Day 56 post-vaccination
Results posted on
2012-08-20
Participant Flow
Participants were enrolled from 18 May 2005 to 07 September 2005 at 1clinical center in the United States.
A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
ChimeriVax™-JE After Placebo
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
|
JE-VAX®
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
ChimeriVax™-JE After Placebo
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
|
JE-VAX®
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
Baseline characteristics by cohort
| Measure |
ChimeriVax™-JE After Placebo
n=30 Participants
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
|
JE-VAX®
n=30 Participants
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
|
Total
n=60 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
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
32.7 Years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
29.2 Years
STANDARD_DEVIATION 9.14 • n=7 Participants
|
31 Years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and up to Day 56 post-vaccinationPopulation: Seroconversion was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of \< 1:10.
Outcome measures
| Measure |
ChimeriVax™-JE After Placebo
n=29 Participants
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
|
JE-VAX®
n=26 Participants
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
|
|---|---|---|
|
Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine
Day 14
|
0 Participants
|
7 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine
Day 28
|
0 Participants
|
16 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine
Day 42
|
18 Participants
|
24 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine
Day 56
|
29 Participants
|
21 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 0 up to Day 56 post-vaccinationPopulation: Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per Protocol Population).
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Outcome measures
| Measure |
ChimeriVax™-JE After Placebo
n=29 Participants
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
|
JE-VAX®
n=26 Participants
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
|
|---|---|---|
|
Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
Day 0
|
5.0 1/dilutions
Standard Deviation 0.0 • Interval 5.0 to 5.0
|
5.0 1/dilutions
Standard Deviation 0.0 • Interval 5.0 to 5.0
|
|
Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
Day 14
|
5.0 1/dilutions
Standard Deviation 0.0 • Interval 5.0 to 10240.0
|
15.2 1/dilutions
Standard Deviation 31.16 • Interval 5.0 to 160.0
|
|
Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
Day 28
|
5.0 1/dilutions
Standard Deviation 0.0
|
36.5 1/dilutions
Standard Deviation 55.91
|
|
Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
Day 42
|
599.8 1/dilutions
Standard Deviation 1915.35
|
184.6 1/dilutions
Standard Deviation 284.42
|
|
Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
Day 56
|
3115.9 1/dilutions
Standard Deviation 4147.71
|
66.0 1/dilutions
Standard Deviation 133.28
|
PRIMARY outcome
Timeframe: Day 0 (Pre-vaccination) and up to Month 12 After First DosePopulation: Seropositive status was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. \[Seropositive status can be 'Yes' or 'No'\]
Outcome measures
| Measure |
ChimeriVax™-JE After Placebo
n=29 Participants
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
|
JE-VAX®
n=26 Participants
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
|
|---|---|---|
|
Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.
Day 0 (N = 29, 26)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.
Day 56 (N = 29, 26)
|
29 Participants
|
23 Participants
Interval 0.0 to 0.0
|
|
Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.
Month 6 (N = 26, 24)
|
24 Participants
|
7 Participants
Interval 0.0 to 0.0
|
|
Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.
Month 12 (N = 26, 22)
|
24 Participants
|
4 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) up to month 12 post-vaccinationPopulation: Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Outcome measures
| Measure |
ChimeriVax™-JE After Placebo
n=29 Participants
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
|
JE-VAX®
n=26 Participants
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
|
|---|---|---|
|
Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®
Day 0 (N = 29, 26)
|
5.0 1/dilutions
Standard Deviation 0.0 • Interval 5.0 to 5.0
|
5.0 1/dilutions
Standard Deviation 0.0 • Interval 5.0 to 5.0
|
|
Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®
Day 56 (N = 29, 26)
|
3115.9 1/dilutions
Standard Deviation 4147.71 • Interval 40.0 to 10240.0
|
485.6 1/dilutions
Standard Deviation 994.74 • Interval 5.0 to 640.0
|
|
Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®
Month 6 (N = 26, 24)
|
1727.3 1/dilutions
Standard Deviation 3308.16 • Interval 5.0 to 10240.0
|
44.4 1/dilutions
Standard Deviation 131.47 • Interval 5.0 to 640.0
|
|
Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®
Month 12 (N = 26, 22)
|
228.1 1/dilutions
Standard Deviation 342.01 • Interval 5.0 to 1280.0
|
17.3 1/dilutions
Standard Deviation 36.24 • Interval 5.0 to 160.0
|
PRIMARY outcome
Timeframe: Day 0 up to Day 6 post-vaccinationPopulation: Adverse events were assessed in all participants who received at least one dose of study vaccine pr saline (Intent to Treat Population).
Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.
Outcome measures
| Measure |
ChimeriVax™-JE After Placebo
n=30 Participants
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
|
JE-VAX®
n=30 Participants
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
|
|---|---|---|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Eye pain
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Eye Pain
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Photophobia
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Photophobia
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Abdominal Pain
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Abdominal Pain
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Diarrhoea
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Diarrhoea
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Nausea
|
1 Participants
|
4 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Nausea
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Vomiting
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Vomiting
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Chills
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Chills
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Fatigue
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Fatigue
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Feeling Hot
|
6 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Feeling Hot
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Injection Site Erythema
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Injection Site Erythema
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Injection Site Haemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Injection Site Haemorrhage
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Injection Site Pain
|
3 Participants
|
19 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Injection Site Pain
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Malaise
|
6 Participants
|
9 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Malaise
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Contusion
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Contusion
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Excoriation
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Excoriation
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Limb Injury
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Limb Injury
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Body Temperature Increased
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Body Temperature Increased
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Arthralgia
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Arthralgia
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Myalgia
|
4 Participants
|
6 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Myalgia
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Disturbance in Attention
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Disturbance in Attention
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Dizziness
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Dizziness
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Headache
|
13 Participants
|
9 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Headache
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Lethargy
|
4 Participants
|
7 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Lethargy
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Somnolence
|
8 Participants
|
6 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Somnolence
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Pollakiuria
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Pollakiuria
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Dyspnoea
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Dyspnoea
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Pharyngolaryngeal Pain
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Pharyngolaryngeal Pain
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Sinus Congestion
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Sinus Congestion
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Erythema
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Erythema
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Pruritus
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Pruritus
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Rash
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 Rash
|
0 Participants
|
0 Participants
|
Adverse Events
ChimeriVax™-JE After Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
JE-VAX®
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ChimeriVax™-JE After Placebo
n=30 participants at risk
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
|
JE-VAX®
n=30 participants at risk
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
|
|---|---|---|
|
Eye disorders
Eye pain
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Eye disorders
Photophobia
|
10.0%
3/30 • Number of events 3 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
5/30 • Number of events 6 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
0.00%
0/30 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
6/30 • Number of events 6 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
16.7%
5/30 • Number of events 8 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
3/30 • Number of events 3 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
16.7%
5/30 • Number of events 5 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
General disorders
Chills
|
20.0%
6/30 • Number of events 6 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
General disorders
Fatigue
|
23.3%
7/30 • Number of events 8 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
16.7%
5/30 • Number of events 5 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
General disorders
Feeling Hot
|
33.3%
10/30 • Number of events 11 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
0.00%
0/30 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
General disorders
Injection Site Erythema
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
30.0%
9/30 • Number of events 19 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
General disorders
Injection Site Haemorrhage
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
General disorders
Injection Site Induration
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
General disorders
Injection Site Pain
|
13.3%
4/30 • Number of events 9 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
80.0%
24/30 • Number of events 70 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/30 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
6.7%
2/30 • Number of events 3 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
General disorders
Injection Site Swelling
|
0.00%
0/30 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
20.0%
6/30 • Number of events 8 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
General disorders
Malaise
|
30.0%
9/30 • Number of events 10 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
36.7%
11/30 • Number of events 11 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.0%
3/30 • Number of events 3 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
2/30 • Number of events 3 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
10.0%
3/30 • Number of events 4 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Injury, poisoning and procedural complications
Sunburn
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
0.00%
0/30 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Investigations
White Blood Cell Count Increased
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
6.7%
2/30 • Number of events 3 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Investigations
White Blood Cells Urine Positive
|
13.3%
4/30 • Number of events 4 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
10.0%
3/30 • Number of events 4 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • Number of events 3 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
10.0%
3/30 • Number of events 3 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
6/30 • Number of events 7 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
23.3%
7/30 • Number of events 8 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Nervous system disorders
Headache
|
56.7%
17/30 • Number of events 28 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
40.0%
12/30 • Number of events 25 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Nervous system disorders
Lethargy
|
16.7%
5/30 • Number of events 8 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
26.7%
8/30 • Number of events 10 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Nervous system disorders
Somnolence
|
30.0%
9/30 • Number of events 11 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
23.3%
7/30 • Number of events 7 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
10.0%
3/30 • Number of events 3 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
13.3%
4/30 • Number of events 4 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
0.00%
0/30 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/30 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/30 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected from Day 0 after vaccination up to Month 12.
|
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