Japanese Encephalitis, Japanese Encephalitis Virus Disease
Conditions
Keywords
Japanese Encephalitis, Japanese Encephalitis Virus Disease, IMOJEV™, CD.JEVAX™
Brief summary
The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine \[CD.JEVAX™\]) after a single dose vaccination to support product registration. Primary Objective: * To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine. Secondary Objectives: * To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine. * To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.
Detailed description
All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months post-vaccination.
Interventions
BIOLOGICALLive attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous
BIOLOGICALJapanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)
0.5 mL, Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 12 to 24 months on the day of inclusion * In good general health, without significant medical history. * Provision of informed consent form signed by at least one parent or other legally acceptable representative. * Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
Exclusion criteria
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination. * Planned participation in another clinical trial during the present trial period. * Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. * Known systemic hypersensitivity to any of IMOJEV™ components or history of a life-threatening reaction to a vaccine containing any of the same substances and vaccination,known systemic hypersensitivity to CD.JEVAX® main components and the other components (including Gelatin, kanamycin, and gentamicin). * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. * Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response. * Previous vaccination against flavivirus disease, including Japanese encephalitis (JE). * Administration of any anti-viral within 2 months preceding Visit 01 and up to the 4 weeks following the trial vaccination. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines. * Planned receipt of any vaccine from the inclusion up to the 4 weeks following the trial vaccination. * History of central nervous system disorder or disease, including seizures. * Planned receipt of any JE vaccine during the course of the study. * History of flavivirus infection (confirmed either clinically, serologically or virologically). * Administration of systemic corticosteroids for more than two consecutive weeks within the 4 weeks preceding vaccination. * Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment. * Thrombocytopenia or bleeding disorder contraindicated for vaccination with same administration route, or receipt of anticoagulants in the 3 weeks preceding inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Day 28 post-vaccination | Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (\<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). JE-CV PRNT50 antibody titer \>10 (1/dil, Day 0) |
| Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination. |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Day 0 up to Day 14 post-vaccination | Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever \>39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \>3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable. |
Countries
South Korea
Participant flow
Recruitment details
The study participants were enrolled from 12 July 2011 to 28 September 2012 at 10 clinic centers in South Korea.
Pre-assignment details
A total of 274 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| IMOJEV™ Vaccine Group Participants age 12 to 24 months received one dose of IMOJEV™ | 137 |
| CD.JEVAX™ Vaccine Group Participants age 12 to 24 months received one dose of CD.JEVAX™ | 137 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | CD.JEVAX™ Vaccine Group | IMOJEV™ Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 137 Participants | 137 Participants | 274 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.3 Months STANDARD_DEVIATION 2.2 | 14.0 Months STANDARD_DEVIATION 2 | 14.2 Months STANDARD_DEVIATION 2.1 |
| Region of Enrollment South Korea | 137 Participants | 137 Participants | 274 Participants |
| Sex: Female, Male Female | 57 Participants | 58 Participants | 115 Participants |
| Sex: Female, Male Male | 80 Participants | 79 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 74 / 137 | 69 / 137 |
| serious Total, serious adverse events | 17 / 137 | 18 / 137 |
Outcome results
Primary
Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (\<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.
Time frame: Day 28 post-vaccination
Population: Seroconversion to JE-CV was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IMOJEV™ Vaccine Group | Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | 100 Percentage of Participants |
| CD.JEVAX™ Vaccine Group | Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | 99.1 Percentage of Participants |
Secondary
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). JE-CV PRNT50 antibody titer \>10 (1/dil, Day 0)
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean titers against the JE-CV was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| IMOJEV™ Vaccine Group | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | JE-CV PRNT50 antibody titer (pre-vaccination) | 5.0 Titers |
| IMOJEV™ Vaccine Group | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | JE-CV PRNT50 antibody titer (post-vaccination) | 908 Titers |
| CD.JEVAX™ Vaccine Group | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | JE-CV PRNT50 antibody titer (pre-vaccination) | 5.0 Titers |
| CD.JEVAX™ Vaccine Group | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | JE-CV PRNT50 antibody titer (post-vaccination) | 579 Titers |
Secondary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever \>39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \>3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.
Time frame: Day 0 up to Day 14 post-vaccination
Population: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Injection site Pain (N = 137, 137) | 35 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Injection site Pain (N = 137, 137) | 0 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Injection site Erythema (N = 137, 137) | 23 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Injection site Swelling (N = 137, 137) | 6 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Injection site Swelling (N = 137, 137) | 0 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Fever (N = 134, 136) | 33 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Fever (N = 134, 136) | 1 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Vomiting (N = 137, 137) | 9 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Vomiting (N = 137, 137) | 1 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Crying Abnormal (N = 137, 137) | 27 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Crying Abnormal (N = 137, 137) | 2 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Drowsiness (N = 137, 137) | 23 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Drowsiness (N = 137, 137) | 0 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Appetite Loss (N = 137, 137) | 38 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Irritability (N = 137, 137) | 1 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Injection site Erythema (N = 137, 137) | 0 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Appetite Loss (N = 137, 137) | 4 Participants |
| IMOJEV™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Irritability (N = 137, 137) | 31 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Crying Abnormal (N = 137, 137) | 35 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Irritability (N = 137, 137) | 5 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Injection site Pain (N = 137, 137) | 1 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Crying Abnormal (N = 137, 137) | 3 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Injection site Erythema (N = 137, 137) | 33 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Injection site Erythema (N = 137, 137) | 0 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Injection site Pain (N = 137, 137) | 38 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Injection site Swelling (N = 137, 137) | 10 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Drowsiness (N = 137, 137) | 33 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Injection site Swelling (N = 137, 137) | 0 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Appetite Loss (N = 137, 137) | 1 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Fever (N = 134, 136) | 34 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Fever (N = 134, 136) | 1 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Appetite Loss (N = 137, 137) | 40 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Vomiting (N = 137, 137) | 14 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Irritability (N = 137, 137) | 36 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Vomiting (N = 137, 137) | 2 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | Grade 3 Drowsiness (N = 137, 137) | 1 Participants |
Secondary
Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Seroprotection against JE-CV was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IMOJEV™ Vaccine Group | Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 28) | 119 Participants |
| IMOJEV™ Vaccine Group | Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 0) | 0 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 0) | 0 Participants |
| CD.JEVAX™ Vaccine Group | Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine | JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 28) | 116 Participants |