Encephalitis, Japanese Encephalitis
Conditions
Keywords
Encephalitis, Japanese Encephalitis, Japanese Encephalitis Vaccines, Infant
Brief summary
The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in infants and toddlers. Primary Objective: * To demonstrate the non-inferiority of the antibody response 28 days after vaccine administration of one dose of JE CV (administered on Day 0) compared to the antibody response after one dose of the SA14-14-2 control vaccine (administered on Day 0). Secondary Objectives: * To describe the immune response to JE in both vaccine groups in JE-CV virus and SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2 vaccine * To describe the safety profile in all vaccinated subjects up to 28 days and all serious adverse events (SAEs) up to 6 months after vaccination. * To describe only related SAEs and all death from 6 month to 12-month follow-up.
Detailed description
All participants will receive one injection of their randomized vaccine on Day 0. Follow-up will continue for 12 months after vaccination.
Interventions
BIOLOGICALJapanese encephalitis chimeric virus vaccine (JE-CV)
0.5 mL, Subcutaneous
BIOLOGICALJapanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)
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
9 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
: * Aged 9 to 18 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, and by at least one independent witness if required by local regulations * Subject and parent/legally acceptable representatives able to attend all scheduled visits and comply with all trial procedures * Completion of vaccinations according to the national immunization schedule.
Exclusion criteria
: * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances * 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 first vaccination and up to the 4 weeks following the last trial vaccination at Month 3 * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination * Planned receipt of any vaccine from the inclusion up to the 4 weeks following the last trial vaccination * Planned receipt of any Japanese encephalitis vaccine during the course of the study * History of central nervous system disorder or disease, including seizures * History of flavivirus infection (confirmed either clinically, serologically or microbiologically) * Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | Day 0 through Day 28 after vaccination | Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50). Japanese Encephalitis seroconversion was defined as a pre-vaccination titer \<10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 28 post-vaccination | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12. |
| Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | Day 28 post-vaccination | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Seroconversion was defined as a pre-vaccination titer \< 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination. |
| Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 0 (pre-vaccination) and Day 28 post-vaccination | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. |
| Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 28 up to 12 months post-vaccination | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12. |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Day 0 through Day 14 post-vaccination | Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability. Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature \> 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable. |
Countries
Thailand
Participant flow
Recruitment details
Participants were enrolled from 07 March 2010 to 27 April 2011 at 3 clinical centers in Thailand.
Pre-assignment details
A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled; 299 were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Japanese Encephalitis Chimeric Vaccine (JE-CV) Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0. | 149 |
| Japanese Encephalitis Live Vaccine (SA14-14-2) Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0. | 150 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Japanese Encephalitis Live Vaccine (SA14-14-2) | Japanese Encephalitis Chimeric Vaccine (JE-CV) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 150 Participants | 149 Participants | 299 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 | 13.2 Months STANDARD_DEVIATION 1.89 | 13.1 Months STANDARD_DEVIATION 2.11 | 13.2 Months STANDARD_DEVIATION 2 |
| Region of Enrollment Thailand | 150 Participants | 149 Participants | 299 Participants |
| Sex: Female, Male Female | 75 Participants | 69 Participants | 144 Participants |
| Sex: Female, Male Male | 75 Participants | 80 Participants | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 66 / 147 | 88 / 152 |
| serious Total, serious adverse events | 14 / 147 | 18 / 152 |
Outcome results
Primary
Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)
Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50). Japanese Encephalitis seroconversion was defined as a pre-vaccination titer \<10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination.
Time frame: Day 0 through Day 28 after vaccination
Population: Japanese encephalitis antibody titers were assessed in all participants with immunogenicity data and who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | 125 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | 127 Participants |
Secondary
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®)
Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability. Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature \> 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable.
Time frame: Day 0 through Day 14 post-vaccination
Population: Solicited injection site and systemic reactions were assessed in all participants who received a study vaccination and for whom safety data were available, according to the vaccine actually received (Safety Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any injection site Tenderness | 44 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 injection site Tenderness | 0 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any injection site Erythema | 26 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 injection site Erythema | 0 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any injection site Swelling | 9 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 injection site Swelling | 0 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Fever | 24 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Fever | 0 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Vomiting | 21 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Vomiting | 1 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Crying Abnormal | 28 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Crying Abnormal | 1 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Drowsiness | 25 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Drowsiness | 0 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Appetite Loss | 32 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Appetite Loss | 0 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Irritability | 41 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Irritability | 0 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Drowsiness | 0 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any injection site Tenderness | 57 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Vomiting | 2 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 injection site Tenderness | 1 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Irritability | 5 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any injection site Erythema | 35 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Crying Abnormal | 39 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 injection site Erythema | 0 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Appetite Loss | 54 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any injection site Swelling | 12 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Crying Abnormal | 2 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 injection site Swelling | 0 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Irritability | 58 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Fever | 33 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Drowsiness | 38 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Fever | 1 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Grade 3 Appetite Loss | 3 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Any Vomiting | 40 Participants |
Secondary
Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)
Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12.
Time frame: Day 28 post-vaccination
Population: Japanese encephalitis antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 0, JE-CV PRNT50 (N = 127, 129) | 0 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 28, JE-CV PRNT50 (N = 125, 128) | 125 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 0, SA14-14-2 PRNT50 (N = 125, 128) | 0 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 28, SA14-14-2 PRNT50 (N = 125, 126) | 122 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 28, SA14-14-2 PRNT50 (N = 125, 126) | 123 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 0, JE-CV PRNT50 (N = 127, 129) | 0 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 0, SA14-14-2 PRNT50 (N = 125, 128) | 0 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 28, JE-CV PRNT50 (N = 125, 128) | 127 Participants |
Secondary
Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)
Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Seroconversion was defined as a pre-vaccination titer \< 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination.
Time frame: Day 28 post-vaccination
Population: Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | JE-CV PRNT50 (N = 126, 128) | 125 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | SA14-14-2 PRNT50 (N = 124, 125) | 121 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | JE-CV PRNT50 (N = 126, 128) | 127 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | SA14-14-2 PRNT50 (N = 124, 125) | 122 Participants |
Secondary
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)
Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 0, JE-CV PRNT50 (N = 127, 129) | 5.0 Titers |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 28, JE-CV PRNT50 (N = 126, 128) | 491 Titers |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 0, SA14-14-2 PRNT50 (N = 125, 128) | 5.00 Titers |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 28, SA14-14-2 PRNT50 (N = 125, 126) | 205 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 28, SA14-14-2 PRNT50 (N = 125, 126) | 190 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 0, JE-CV PRNT50 (N = 127, 129) | 5.0 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 0, SA14-14-2 PRNT50 (N = 125, 128) | 5.0 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 28, JE-CV PRNT50 (N = 126, 128) | 395 Titers |
Secondary
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)
Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.
Time frame: Day 0 (pre-vaccination) and up to 12 months post-vaccination
Population: Japanese encephalitis antibody titers were assessed in all participants that received a vaccine and with available immunogenicity data (Full Analysis Set)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 0, JE-CV PRNT50 (N = 149, 150) | 5.39 Titers |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 28, JE-CV PRNT50 (N = 146, 148) | 507 Titers |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Month 6, JE-CV PRNT50 (N = 145, 145) | 119 Titers |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Month 12, JE-CV PRNT50 (N = 143, 146) | 97.6 Titers |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 0, SA14-14-2 PRNT50 (N = 147, 149) | 5.00 Titers |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 28, SA14-14-2 PRNT50 (N = 145, 146) | 198 Titers |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Month 6, SA14-14-2 PRNT50 (N = 145, 145) | 52.7 Titers |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Month 12, SA14-14-2 PRNT50 (N = 142, 144) | 46.5 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Month 12, SA14-14-2 PRNT50 (N = 142, 144) | 54.8 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 0, JE-CV PRNT50 (N = 149, 150) | 5.29 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 0, SA14-14-2 PRNT50 (N = 147, 149) | 5.00 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 28, JE-CV PRNT50 (N = 146, 148) | 370 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Month 6, SA14-14-2 PRNT50 (N = 145, 145) | 51.4 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Month 6, JE-CV PRNT50 (N = 145, 145) | 103 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Day 28, SA14-14-2 PRNT50 (N = 145, 146) | 171 Titers |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Month 12, JE-CV PRNT50 (N = 143, 146) | 121 Titers |
Secondary
Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)
Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12.
Time frame: Day 28 up to 12 months post-vaccination
Population: Japanese encephalitis antibody titers were assessed in all vaccinated participants with available immunogenicity data (Full Analysis Set)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 0, JE-CV PRNT50 (N = 149, 150) | 6 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 28, JE-CV PRNT50 (N = 146, 148) | 145 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Month 6, JE-CV PRNT50 (N = 145, 145) | 137 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Month 12, JE-CV PRNT50 (N = 143, 146) | 126 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 0, SA14-14-2 PRNT50 (N = 147, 149) | 0 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 28, SA14-14-2 PRNT50 (N = 145, 146) | 141 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Month 6, SA14-14-2 PRNT50 (N = 145, 145) | 122 Participants |
| Japanese Encephalitis Chimeric Vaccine (JE-CV) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Month 12, SA14-14-2 PRNT50 (N = 142, 144) | 109 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Month 12, SA14-14-2 PRNT50 (N = 142, 144) | 126 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 0, JE-CV PRNT50 (N = 149, 150) | 5 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 0, SA14-14-2 PRNT50 (N = 147, 149) | 0 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 28, JE-CV PRNT50 (N = 146, 148) | 147 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Month 6, SA14-14-2 PRNT50 (N = 145, 145) | 129 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Month 6, JE-CV PRNT50 (N = 145, 145) | 141 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Day 28, SA14-14-2 PRNT50 (N = 145, 146) | 142 Participants |
| Japanese Encephalitis Live Vaccine (SA14-14-2) | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Month 12, JE-CV PRNT50 (N = 143, 146) | 142 Participants |