Japanese Encephalitis
Conditions
Brief summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.
Interventions
BIOLOGICALChimeriVax™-JE
0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)
BIOLOGICALJE-VAX®
0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)
Sponsors
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 No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects aged 18 or above * Subjects in good general health. * Females must have negative pregnancy test and be using adequate form of contraception
Exclusion criteria
* History of vaccination/infection with JE or Yellow fever or other flaviviruses * History of residence/travel to flavivirus endemic regions * History of anaphylaxis/serious adverse reactions * Administration of vaccine within 30 days of study or during treatment period * Clinically significant physical exam/medical history/lab abnormalities * Pregnancy * Excessive alcohol/drug abuse * Hypersensitivity to constituents of JE-VAX® * Blood transfusion/treatment with blood product within 6months of study and during study treatment period * Known/suspected immunodeficiency * Compromised blood brain barrier * Employees of Clinical Research Organization (CRO)/study site staff * Any other condition which would exclude subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Up to Day 60 post-first vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10. |
| Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Day 0 (Pre-vaccination) up to 60 days post-first vaccination | Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported. Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Up to Day 60 post-first vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). |
| Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Day 60 post-first vaccination | Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). |
Countries
Australia, United States
Participant flow
Recruitment details
Participants were enrolled and treated from 07 November 2005 to 15 November 2006 at 5 clinical centers in Australia and 5 clinical centers in the US.
Pre-assignment details
A total of 820 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| JE-VAX® All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30. | 410 |
| ChimeriVax™-JE All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms. | 410 |
| Total | 820 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Lost to Follow-up | 5 | 12 |
| Overall Study | Physician Decision | 3 | 4 |
| Overall Study | Protocol Violation | 3 | 0 |
| Overall Study | Sponsor Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 10 |
Baseline characteristics
| Characteristic | JE-VAX® | ChimeriVax™-JE | 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 | 410 Participants | 410 Participants | 820 Participants |
| Age Continuous | 37.0 Years STANDARD_DEVIATION 14.81 | 37.7 Years STANDARD_DEVIATION 15.11 | 37.4 Years STANDARD_DEVIATION 14.96 |
| Region of Enrollment Australia | 203 Participants | 120 Participants | 323 Participants |
| Region of Enrollment United States | 207 Participants | 290 Participants | 497 Participants |
| Sex: Female, Male Female | 205 Participants | 217 Participants | 422 Participants |
| Sex: Female, Male Male | 205 Participants | 193 Participants | 398 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 262 / 410 | 193 / 410 |
| serious Total, serious adverse events | 3 / 410 | 2 / 410 |
Outcome results
Primary
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported. Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.
Time frame: Day 0 (Pre-vaccination) up to 60 days post-first vaccination
Population: Treatment emergent local adverse events and systemic reactions were assessed in all subjects who had at least one injection (ChimeriVax™-JE, JE-Vax®, or placebo), according to the treatment actually received (Safety Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Joint Pain | 1 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Fatigue | 131 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Joint Movement Impairment | 0 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Reaction | 1 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Warmth | 0 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Pyrexia | 18 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Malaise | 113 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Pain | 262 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Chills | 32 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Swelling | 85 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Headache | 190 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Erythema | 123 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Myalgia | 107 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Discomfort | 1 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Arthralgia | 58 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Edema | 2 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Diarrhea | 56 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Hemorrhage | 20 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Nausea | 53 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Venipuncture Site Bruise | 1 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Vomiting | 15 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Rash | 6 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Rash | 26 Participants |
| JE-VAX® | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Pruritus | 107 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Rash | 23 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Pruritus | 29 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Rash | 2 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Joint Pain | 1 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Reaction | 1 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Warmth | 1 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Venipuncture Site Bruise | 0 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Chills | 43 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Pain | 105 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Erythema | 27 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Swelling | 15 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Hemorrhage | 14 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Edema | 0 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Discomfort | 0 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Injection Site Joint Movement Impairment | 1 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Fatigue | 152 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Malaise | 113 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Pyrexia | 14 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Headache | 193 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Myalgia | 105 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Arthralgia | 58 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Diarrhea | 57 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Nausea | 56 Participants |
| ChimeriVax™-JE | Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® | Vomiting | 13 Participants |
Primary
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Time frame: Up to Day 60 post-first vaccination
Population: Seroconversion was assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-VAX® | Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Day 44 (N = 0, 346) | NA Participants |
| JE-VAX® | Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Day 60 (N = 365, 346) | 273 Participants |
| ChimeriVax™-JE | Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Day 44 (N = 0, 346) | 324 Participants |
| ChimeriVax™-JE | Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Day 60 (N = 365, 346) | 343 Participants |
Secondary
Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Time frame: Up to Day 60 post-first vaccination
Population: Geometric mean titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| JE-VAX® | Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Day 44 (N = 0, 346) | NA Titers |
| JE-VAX® | Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Day 60 (N = 365, 346) | 37.4 Titers |
| ChimeriVax™-JE | Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Day 44 (N = 0, 346) | 312.3 Titers |
| ChimeriVax™-JE | Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Day 60 (N = 365, 346) | 1391.7 Titers |
Secondary
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Time frame: Day 60 post-first vaccination
Population: Antibody titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-VAX® | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer < 10 | 63 Participants |
| JE-VAX® | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer 40 to < 160 | 151 Participants |
| JE-VAX® | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer 160 to < 640 | 63 Participants |
| JE-VAX® | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer 10 to < 20 | 29 Participants |
| JE-VAX® | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer 20 to < 40 | 51 Participants |
| JE-VAX® | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer 640 to < 2560 | 6 Participants |
| JE-VAX® | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer ≥ 2560 | 2 Participants |
| ChimeriVax™-JE | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer 640 to < 2560 | 75 Participants |
| ChimeriVax™-JE | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer 20 to < 40 | 4 Participants |
| ChimeriVax™-JE | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer 40 to < 160 | 18 Participants |
| ChimeriVax™-JE | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer 160 to < 640 | 76 Participants |
| ChimeriVax™-JE | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer < 10 | 3 Participants |
| ChimeriVax™-JE | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer ≥ 2560 | 170 Participants |
| ChimeriVax™-JE | Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination | Titer 10 to < 20 | 0 Participants |