Japanese Encephalitis
Conditions
Keywords
Japanese Encephalitis, Japanese encephalitis chimeric virus vaccine, IMOJEV®, Live attenuated vaccine
Brief summary
The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity, reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data from other Asian pediatric populations. Primary objective: \- To describe the safety profile of a single dose of IMOJEV®. Secondary objectives: * To evaluate the immune response to JE 28 days after the administration of a single dose of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.
Detailed description
Study participants will be enrolled by age group and will each receive one injection of IMOJEV® on Day 0 given as primary vaccination. They will be assessed for immunogenicity and safety, post-vaccination.
Interventions
BIOLOGICALLive attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
0.5 mL, Subcutaneous
Sponsors
National Institute of Hygiene and Epidemiology, Vietnam
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 9 months through 60 years on the day of inclusion. * For adults: Informed consent form has been signed and dated by the subject. For minors: Informed consent form has been signed and dated by the parent or legally acceptable representative. In addition, in accordance with the Institution Ethics Committee / Institution Review Board requirements and as appropriate for the age of the subject, the subject may be required to sign and date the informed consent form if aged 12 to 17 years or assent form if aged 8 to 11 years. * Subject and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and comply with all study procedures.
Exclusion criteria
* Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination). * Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure. * Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine * Previous vaccination against flavivirus disease, including Japanese Encephalitis (JE), dengue, and yellow fever. * Receipt of immune globulins, blood, or blood-derived products in the past 3 months that might interfere with the assessment of the immune response. * 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 (for more than 2 consecutive weeks within the 4 weeks preceding vaccination). * History of flavivirus infection (confirmed either clinically, serologically, or virologically). * History of central nervous system disorder or disease, including seizures. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances. * Known thrombocytopenia, contraindicating vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating vaccination. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction. * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion. * Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. * Receipt of any chronic anti-viral in the 2 months preceding the study vaccination or planned receipt of any anti-viral in the 4 weeks following the study vaccination. Short-term antiviral drugs for flu or herpes can be administered provided there is a wash-out period of 1 week before the administration of the vaccine. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Day 0 up to Day 14 post-vaccination | Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia. Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or \>100 mm (≥ 12 years). Grade 3 Fever, \> 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, \> 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity. |
| Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Day 0 (pre-vaccination) and Day 28 post-vaccination | Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil). |
| Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Day 0 (pre-vaccination) and Day 28 post-vaccination | Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination. |
| Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Day 0 (pre-vaccination) and Day 28 post-vaccination | Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). |
Countries
Vietnam
Participant flow
Recruitment details
Study participants were enrolled from 27 June 2015 to 24 August 2015 at 1 clinic center in Vietnam.
Pre-assignment details
A total of 250 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| 9 Months to 4 Years Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). | 100 |
| 5 to 11 Years Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). | 60 |
| 12 to 17 Years Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). | 60 |
| 18 to 60 Years Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). | 30 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 9 Months to 4 Years | 5 to 11 Years | 12 to 17 Years | 18 to 60 Years | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 100 Participants | 60 Participants | 60 Participants | 0 Participants | 220 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 30 Participants | 30 Participants |
| Age, Continuous Age Continuous | 0.7 Years STANDARD_DEVIATION 0.6 | 8.7 Years STANDARD_DEVIATION 1.5 | 13.9 Years STANDARD_DEVIATION 1.4 | 38.7 Years STANDARD_DEVIATION 10 | 15.75 Years STANDARD_DEVIATION 3.375 |
| Region of Enrollment Vietnam | 100 Participants | 60 Participants | 60 Participants | 30 Participants | 250 Participants |
| Sex: Female, Male Female | 46 Participants | 31 Participants | 42 Participants | 22 Participants | 141 Participants |
| Sex: Female, Male Male | 54 Participants | 29 Participants | 18 Participants | 8 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 38 / 100 | 9 / 60 | 16 / 60 | 10 / 30 |
| serious Total, serious adverse events | 1 / 100 | 0 / 60 | 1 / 60 | 0 / 30 |
Outcome results
Primary
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia. Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or \>100 mm (≥ 12 years). Grade 3 Fever, \> 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, \> 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity.
Time frame: Day 0 up to Day 14 post-vaccination
Population: Solicited injection site and solicited systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Fever | 14 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Tenderness/Pain | 0 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Erythema | 6 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Erythema | 0 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Swelling | 1 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Swelling | 0 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Tenderness/Pain | 35 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Fever | 2 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Vomiting | 12 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Vomiting | 0 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Crying abnormal | 20 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Crying abnormal | 0 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Drowsiness | 12 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Drowsiness | 0 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Appetite loss | 38 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Appetite loss | 1 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Irritability | 21 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Irritability | 0 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Headache | NA Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Headache | NA Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Malaise | 1 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Malaise | 0 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Myalgia | 0 Participants |
| 9 Months to 4 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Myalgia | 0 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Myalgia | 0 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Drowsiness | NA Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Erythema | 0 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Myalgia | 5 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Malaise | 0 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Drowsiness | NA Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Vomiting | NA Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Irritability | NA Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Swelling | 0 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Appetite loss | NA Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Erythema | 3 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Appetite loss | NA Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Malaise | 8 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Vomiting | NA Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Headache | 0 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Tenderness/Pain | 0 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Fever | 1 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Crying abnormal | NA Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Fever | 0 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Headache | 9 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Tenderness/Pain | 8 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Crying abnormal | NA Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Swelling | 1 Participants |
| 5 to 11 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Irritability | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Crying abnormal | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Fever | 0 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Fever | 0 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Vomiting | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Vomiting | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Malaise | 16 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Headache | 0 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Crying abnormal | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Drowsiness | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Drowsiness | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Malaise | 0 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Appetite loss | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Appetite loss | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Myalgia | 0 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Irritability | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Irritability | NA Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Myalgia | 9 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Tenderness/Pain | 11 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Tenderness/Pain | 0 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Headache | 14 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Erythema | 0 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Erythema | 0 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Swelling | 0 Participants |
| 12 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Swelling | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Myalgia | 5 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Malaise | 9 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Fever | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Tenderness/Pain | 8 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Crying abnormal | NA Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Vomiting | NA Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Swelling | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Tenderness/Pain | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Swelling | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Vomiting | NA Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Headache | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Injection-site Erythema | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Malaise | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Appetite loss | NA Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Headache | 10 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Appetite loss | NA Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Myalgia | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Drowsiness | NA Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Fever | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Irritability | NA Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Drowsiness | NA Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Crying abnormal | NA Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Injection-site Erythema | 0 Participants |
| 18 to 60 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Grade 3 Irritability | NA Participants |
Primary
Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Seroconversion was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 9 Months to 4 Years | Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | 97.4 Percentage of participants |
| 5 to 11 Years | Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | 100.0 Percentage of participants |
| 12 to 17 Years | Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | 100.0 Percentage of participants |
| 18 to 60 Years | Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | 100.0 Percentage of participants |
Primary
Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Seroprotection was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 9 Months to 4 Years | Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Pre-vaccination (Day 0) | 0.0 Percentage of participants |
| 9 Months to 4 Years | Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Post-vaccination (Day 28) | 97.4 Percentage of participants |
| 5 to 11 Years | Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Post-vaccination (Day 28) | 100.0 Percentage of participants |
| 5 to 11 Years | Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Pre-vaccination (Day 0) | 0.0 Percentage of participants |
| 12 to 17 Years | Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Pre-vaccination (Day 0) | 0.0 Percentage of participants |
| 12 to 17 Years | Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Post-vaccination (Day 28) | 100.0 Percentage of participants |
| 18 to 60 Years | Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Pre-vaccination (Day 0) | 0.0 Percentage of participants |
| 18 to 60 Years | Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Post-vaccination (Day 28) | 100.0 Percentage of participants |
Primary
Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean titers were assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 9 Months to 4 Years | Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Pre-vaccination (Day 0) | 5.00 Titers (1/dil) |
| 9 Months to 4 Years | Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Post-vaccination (Day 28) | 277 Titers (1/dil) |
| 5 to 11 Years | Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Post-vaccination (Day 28) | 1738 Titers (1/dil) |
| 5 to 11 Years | Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Pre-vaccination (Day 0) | 5.00 Titers (1/dil) |
| 12 to 17 Years | Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Post-vaccination (Day 28) | 1481 Titers (1/dil) |
| 12 to 17 Years | Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Pre-vaccination (Day 0) | 5.00 Titers (1/dil) |
| 18 to 60 Years | Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Post-vaccination (Day 28) | 970 Titers (1/dil) |
| 18 to 60 Years | Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) | Pre-vaccination (Day 0) | 5.00 Titers (1/dil) |