Japanese Encephalitis
Conditions
Keywords
Japanese encephalitis, ChimeriVax™-JE, JE-VAX®
Brief summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.
Interventions
BIOLOGICALChimeriVax™-JE vaccine
0.5 mL, subcutaneously
BIOLOGICALJE-VAX® vaccine
1.0 mL, subcutaneously
Sponsors
PRA Health Sciences
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 48 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent obtained. * Aged ≥18 to \<49 years. * In good general health. * Available for the study duration, including all planned follow-up visits. * Females must have negative pregnancy test and be using adequate form of contraception
Exclusion criteria
* Clinically significant abnormalities on laboratory and vital sign assessments. * Anaphylaxis or other serious adverse reactions * Administration of another vaccine within 30 days of study treatment period. * Physical examination indicating any significant medical condition. * Intention to travel out of the area prior to the study visit on Day 56. * Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen. * Pregnancy. * Excessive alcohol consumption, drug abuse. * Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 0 (pre-vaccination) and up to Day 56 post-vaccination | 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. |
| Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE | Day 0 up to Day 56 post-vaccination | 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). |
| 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 (Pre-vaccination) and up to Month 12 After First Dose | 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. \[Seropositive status can be 'Yes' or 'No'\] |
| Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX® | Day 0 (pre-vaccination) up to month 12 post-vaccination | 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). |
| Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Day 0 up to Day 6 post-vaccination | Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 18 May 2005 to 07 September 2005 at 1clinical center in the United States.
Pre-assignment details
A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| JE-VAX® Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | JE-VAX® | ChimeriVax™-JE After Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age Continuous | 29.2 Years STANDARD_DEVIATION 9.14 | 32.7 Years STANDARD_DEVIATION 8.82 | 31 Years STANDARD_DEVIATION 8.98 |
| Region of Enrollment United States | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 30 | 29 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
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).
Time frame: Day 0 up to Day 56 post-vaccination
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| JE-VAX® | Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE | Day 56 | 66.0 1/dilutions | Standard Deviation 133.28 |
| JE-VAX® | Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE | Day 42 | 184.6 1/dilutions | Standard Deviation 284.42 |
| JE-VAX® | Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE | Day 14 | 15.2 1/dilutions | Standard Deviation 31.16 |
| JE-VAX® | 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 |
| JE-VAX® | Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE | Day 28 | 36.5 1/dilutions | Standard Deviation 55.91 |
Primary
Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®
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).
Time frame: Day 0 (pre-vaccination) up to month 12 post-vaccination
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| JE-VAX® | Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX® | Month 12 (N = 26, 22) | 17.3 1/dilutions | Standard Deviation 36.24 |
| JE-VAX® | 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 |
| JE-VAX® | Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX® | Month 6 (N = 26, 24) | 44.4 1/dilutions | Standard Deviation 131.47 |
| JE-VAX® | Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX® | Day 56 (N = 29, 26) | 485.6 1/dilutions | Standard Deviation 994.74 |
Primary
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.
Time frame: Day 0 up to Day 6 post-vaccination
Population: Adverse events were assessed in all participants who received at least one dose of study vaccine pr saline (Intent to Treat Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Malaise | 6 Participants |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Dizziness | 0 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Headache | 13 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Lethargy | 4 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Somnolence | 8 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Pollakiuria | 1 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Dyspnoea | 1 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Pharyngolaryngeal Pain | 1 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Sinus Congestion | 0 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Erythema | 0 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Pruritus | 1 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Rash | 1 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Eye pain | 2 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Photophobia | 3 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Abdominal Pain | 4 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Diarrhoea | 2 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Nausea | 1 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Vomiting | 0 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Chills | 2 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Fatigue | 5 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Feeling Hot | 6 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Contusion | 0 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Excoriation | 1 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Limb Injury | 0 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Arthralgia | 2 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Myalgia | 4 Participants |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Nausea | 4 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Malaise | 9 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Dizziness | 1 Participants |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Grade 3 Dizziness | 1 Participants |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Headache | 9 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Vomiting | 1 Participants |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Grade 3 Malaise | 1 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Lethargy | 7 Participants |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Grade 3 Lethargy | 1 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Body Temperature Increased | 0 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Somnolence | 6 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Chills | 1 Participants |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Contusion | 1 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Pollakiuria | 0 Participants |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Dyspnoea | 3 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Fatigue | 4 Participants |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Pharyngolaryngeal Pain | 0 Participants |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Sinus Congestion | 1 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Feeling Hot | 0 Participants |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Excoriation | 0 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Erythema | 1 Participants |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Myalgia | 6 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Pruritus | 0 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Injection Site Erythema | 2 Participants |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Rash | 0 Participants |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Arthralgia | 3 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Eye pain | 1 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Injection Site Haemorrhage | 0 Participants |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Limb Injury | 1 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Photophobia | 1 Participants |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Disturbance in Attention | 0 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Abdominal Pain | 0 Participants |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Injection Site Pain | 19 Participants |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® | Diarrhoea | 4 Participants |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
| JE-VAX® | 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 |
Primary
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
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.
Time frame: Day 0 (pre-vaccination) and up to Day 56 post-vaccination
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| JE-VAX® | 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 | 21 Participants |
| JE-VAX® | 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 | 7 Participants |
| JE-VAX® | 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 | 24 Participants |
| JE-VAX® | 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 | 16 Participants |
Primary
Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.
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. \[Seropositive status can be 'Yes' or 'No'\]
Time frame: Day 0 (Pre-vaccination) and up to Month 12 After First Dose
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| ChimeriVax™-JE After Placebo | 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 |
| JE-VAX® | 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) | 4 Participants |
| JE-VAX® | 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 |
| JE-VAX® | 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) | 7 Participants |
| JE-VAX® | 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) | 23 Participants |