Japanese Encephalitis
Conditions
Keywords
Japanese Encephalitis
Brief summary
This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period. Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.
Interventions
BIOLOGICALChimeriVax™-JE
One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged \> 3 years and 0.5 ml to children and infants aged \< 3 years administered subcutaneously
BIOLOGICALJapanese Encephalitis Inactivated Mouse Brain Vaccine
Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged \> 3 years and 0.5 ml is given to children and infants aged \< 3 years administered subcutaneously
Sponsors
Sanofi
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 10 Years
Healthy volunteers
Yes
Inclusion criteria
* All aspects of the Protocol explained and written informed consent obtained from the subject's parent or guardian and assent from the child if ≥ 8 years of age. * Aged ≥ 9 months to \< 10 years * In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results * Subject had to be available for the study duration for the study duration, including all planned follow-up visits.
Exclusion criteria
* A history of vaccination against, or infection with, JE or other flaviviruses (e.g. Kyanasur Forest Disease, West Nile virus, dengue fever). Previous JE vaccination was to be determined by history (interview of subject's parent or guardian) or by inspecting the child's official vaccination record. * Demonstration of parasitemia on malaria blood smear at Screening. * History of residence in or travel to a JE-endemic region of India or elsewhere in Asia (for periods of 4 weeks or more). * hypersensitivity to thimerosal or gelatin * Have received a transfusion of blood, blood products or serum globulin in the preceding 6 months, * Have an immunodeficiency or neurological disorder, or take drugs that suppress the immune system, * Have a history of severe reaction to other vaccines, * Have a chronic condition requiring medication, * Intend to travel out of the area during the study period, * Have spent at least 4 weeks in a JE-endemic region, * Plan to receive any other vaccination within the double-blind treatment period, or who have received a vaccination in the month preceding Screening, * Exhibit signs of secondary or tertiary malnutrition, * Are seropositive to human immunodeficiency virus (HIV), Hepatitis B or C, * Have malaria infection, or who have a fever within 3 days before vaccination. * Those with an acute fever, or with previously scheduled vaccinations, may be rescheduled. * Consideration of the routine immunisation schedule should be made such that it is ensured that routine vaccinations due are either given before entry to the trial, or afterwards if delayed because of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Day 14 up to Day 42 Post-vaccination | — |
| Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Day 14 up to Day 42 Post-vaccination | — |
| Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Day 42 Post-vaccination | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil). |
| Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Day 42 Post Dose 1 | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Day 42 Post Dose 1 | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil). |
| Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Day 42 Post-vaccination | Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). |
Countries
India
Participant flow
Recruitment details
Participants were enrolled and vaccinated from 03 January 2007 to 13 January 2009 at 3 clinical centers in India.
Pre-assignment details
A total of 96 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| ChimeriVax™-JE Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | 48 |
| Mouse Brain Derived Vaccine Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. | 48 |
| Total | 96 |
Baseline characteristics
| Characteristic | Mouse Brain Derived Vaccine | ChimeriVax™-JE | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 48 Participants | 48 Participants | 96 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 | 3.7 Years STANDARD_DEVIATION 2.89 | 3.8 Years STANDARD_DEVIATION 2.98 | 3.7 Years STANDARD_DEVIATION 2.52 |
| Region of Enrollment India | 48 Participants | 48 Participants | 96 Participants |
| Sex: Female, Male Female | 21 Participants | 27 Participants | 48 Participants |
| Sex: Female, Male Male | 27 Participants | 21 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 48 | 5 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Time frame: Day 42 Post Dose 1
Population: Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous virus Nakayama strain PRNT (N = 0, 35) | NA Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nakayama PRNT (N = 33, 35) | 7.8 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV PRNT (N = 34, 35) | 313.5 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Indian WT virus PRNT (N = 34, 35) | 60.1 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous JE-CV virus PRNT (N = 34, 0) | 313.5 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Indian WT virus PRNT (N = 34, 35) | 17.1 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous JE-CV virus PRNT (N = 34, 0) | NA Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous virus Nakayama strain PRNT (N = 0, 35) | 8.0 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV PRNT (N = 34, 35) | 49.7 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nakayama PRNT (N = 33, 35) | 8.0 Titers |
Primary
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Time frame: Day 42 Post-vaccination
Population: Seroconversion was assessed all participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination samples (Day 42) for antibody analysis, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous virus Nakayama strain PRNT (N = 0, 35) | NA Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nakayama PRNT (N = 32, 35) | 8 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV PRNT (N = 33, 35) | 33 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Indian WT virus PRNT (N = 33, 35) | 27 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous JE-CV virus PRNT (N = 33, 0) | 33 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Indian WT virus PRNT (N = 33, 35) | 26 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous JE-CV virus PRNT (N = 33, 0) | NA Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous virus Nakayama strain PRNT (N = 0, 35) | 8 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV PRNT (N = 33, 35) | 33 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nakayama PRNT (N = 32, 35) | 8 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time frame: Day 14 up to Day 42 Post-vaccination
Population: Adverse events were assessed in all enrolled participants, intent-to-treat (safety) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nasopharyngitis (All; N = 48, 48) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Otitis Media Acute (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea Infectious (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Dysentery (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hepatitis A (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash Pustular (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Tonsillitis (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Upper Respiratory Tract Infection (All; N=48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Varicella (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Impetigo (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pharyngitis (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Viral Upper Respiratory Tract Infect. (All;N=48,48 | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea (All; N = 48, 48) | 3 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Vomiting (All; N = 48, 48) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Haematochezia (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Mucous Stools (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Constipation (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rhinorrhea (All; N = 48, 48) | 3 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Cough (All; N = 48, 48) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wheezing (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pyrexia (All; N = 48, 48) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Face Edema (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Swelling (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Malaise (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pain (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Irritability (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anorexia (All; N = 48, 48) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anemia (All; N = 48, 48) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Eosinophilia (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Lacrimation Increased (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Laziness (All; N = 48, 48) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Erythema (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injury (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Eosinophil Count Increased (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hemoglobin Decreased (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pyrexia (≥5 to <10 yr; N = 16, 16) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥5 to <10 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pain (≥5 to <10 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Upper Respiratory Tract Infection (≥5 to <10 yr; | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Eosinophil Count Increased (≥5 to <10 yr; N=16, 16 | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Otitis Media Acute (≥2 to <5 yr: N=16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea Infectious (≥2 to <5 yr: N=16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hepatitis A (≥2 to <5 yr: N=16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash Pustular (≥2 to <5 yr: N=16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Tonsillitis (≥2 to <5 yr: N=16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Varicella (≥2 to <5 yr: N=16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Vomiting (≥2 to <5 yr: N=16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥2 to <5 yr: N=16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Swelling (≥2 to <5 yr: N=16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pyrexia (≥2 to <5 yr: N=16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rhinorrhea (≥2 to <5 yr: N=16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea (≥9 mo to <2 yr; N = 16, 16) | 3 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Vomiting (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Haematochezia (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Mucous Stools (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Constipation (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Cough (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rhinorrhea (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wheezing (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Dysentery (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Impetigo (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pharyngitis (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Viral Upper Respiratory Tract Inf (≥9 mo to <2 yr) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anorexia (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anemia (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Eosinophilia (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Irritability (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Face Edema (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Malaise (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Laziness (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Erythema (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injury (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hemoglobin Decreased (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pain (≥5 to <10 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nasopharyngitis (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rhinorrhea (≥9 mo to <2 yr; N = 16, 16) | 3 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Otitis Media Acute (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Upper Respiratory Tract Infection (≥5 to <10 yr; | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea Infectious (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Irritability (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Dysentery (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Eosinophil Count Increased (≥5 to <10 yr; N=16, 16 | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hepatitis A (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wheezing (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash Pustular (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Otitis Media Acute (≥2 to <5 yr: N=16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Tonsillitis (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Upper Respiratory Tract Infection (All; N=48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea Infectious (≥2 to <5 yr: N=16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Varicella (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Impetigo (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hepatitis A (≥2 to <5 yr: N=16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pharyngitis (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Face Edema (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Viral Upper Respiratory Tract Infect. (All;N=48,48 | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash Pustular (≥2 to <5 yr: N=16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Dysentery (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Vomiting (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Tonsillitis (≥2 to <5 yr: N=16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Haematochezia (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hemoglobin Decreased (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Mucous Stools (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Varicella (≥2 to <5 yr: N=16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Constipation (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Impetigo (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rhinorrhea (All; N = 48, 48) | 3 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Vomiting (≥2 to <5 yr: N=16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Cough (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Malaise (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wheezing (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥2 to <5 yr: N=16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pyrexia (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pharyngitis (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Face Edema (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Swelling (≥2 to <5 yr: N=16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Erythema (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Swelling (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pyrexia (≥2 to <5 yr: N=16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Malaise (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Viral Upper Respiratory Tract Inf (≥9 mo to <2 yr) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pain (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rhinorrhea (≥2 to <5 yr: N=16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Irritability (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anorexia (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anemia (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anorexia (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Eosinophilia (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Vomiting (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Lacrimation Increased (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injury (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Laziness (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Haematochezia (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Erythema (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anemia (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Mucous Stools (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injury (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Laziness (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Eosinophil Count Increased (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Constipation (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hemoglobin Decreased (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Eosinophilia (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pyrexia (≥5 to <10 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Cough (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥5 to <10 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
Primary
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time frame: Day 14 up to Day 42 Post-vaccination
Population: Adverse events were assessed all enrolled and vaccinated participants, intent-to-treat (safety) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥5 to <10 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hematochezia (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pain (≥5 to <10 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Upper Respiratory Tract Infection (≥5 to <10 yr) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Impetigo (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥2 to <5 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Swelling (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Swelling (≥2 to <5 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Mucous Stools (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Malaise (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Vomiting (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hematochezia (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pain (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Mucous Stools (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rhinorrhea (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Cough (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Irritability (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rhinorrhea(≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Upper Respiratory Tract Infection (All; N =48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wheezing (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anorexia (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Cough (All; N = 48, 48) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Impetigo (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anemia (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pharyngitis (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Vomiting (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anorexia (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Lacrimation Increased (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anemia (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wheezing (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Irritability (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash (All; N = 48, 48) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Malaise (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pharyngitis (All; N = 48, 48) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pyrexia (≥5 to <10 yr; N = 16, 16) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pyrexia (All; N = 48, 48) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nasopharyngitis (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nasopharyngitis (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Upper Respiratory Tract Infection (All; N =48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Impetigo (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pharyngitis (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Vomiting (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hematochezia (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Mucous Stools (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rhinorrhea (All; N = 48, 48) | 3 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Cough (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wheezing (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pyrexia (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (All; N = 48, 48) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Swelling (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Malaise (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pain (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Irritability (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anorexia (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anemia (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Lacrimation Increased (All; N = 48, 48) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rash (All; N = 48, 48) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pyrexia (≥5 to <10 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥5 to <10 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pain (≥5 to <10 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Upper Respiratory Tract Infection (≥5 to <10 yr) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥2 to <5 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Swelling (≥2 to <5 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Diarrhea (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Vomiting (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Hematochezia (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Mucous Stools (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Cough (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Rhinorrhea(≥9 mo to <2 yr; N = 16, 16) | 3 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wheezing (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Impetigo (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Pharyngitis (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anorexia (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Anemia (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Irritability (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Malaise (≥9 mo to <2 yr; N = 16, 16) | 0 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Injection Site Pain (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16) | 1 Participants |
Secondary
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Time frame: Day 42 Post-vaccination
Population: Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (All; N = 34, 35) | 313.5 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Nakayama Strain (All; N = 33, 35) | 7.8 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (All; N = 34, 35) | 60.1 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥5 to <10 yr; N = 12, 13) | 226.3 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama Strain (≥5 to <10 yr; N =12, 13) | 13.3 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type virus (≥5 to <10 yr; N = 12, 13) | 100.8 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥2 to <5 yr; N = 9, 9) | 254.0 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama Strain (≥2 to <5 yr; N = 9, 9) | 6.3 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (≥2 to <5 yr; N = 9, 9) | 9.3 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥9 mo to <2 yr; N = 13, 13) | 490.2 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama (≥9 mo to <2 yr; N = 12, 13) | 5.3 Titers |
| ChimeriVax™-JE | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (≥9 mo to <2 yr; N = 13, 13) | 136.3 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama (≥9 mo to <2 yr; N = 12, 13) | 5.6 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (All; N = 34, 35) | 49.7 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥2 to <5 yr; N = 9, 9) | 74.1 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Nakayama Strain (All; N = 33, 35) | 8.0 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥9 mo to <2 yr; N = 13, 13) | 55.1 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (All; N = 34, 35) | 17.1 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama Strain (≥2 to <5 yr; N = 9, 9) | 27.2 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥5 to <10 yr; N = 12, 13) | 34.1 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (≥9 mo to <2 yr; N = 13, 13) | 17.0 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama Strain (≥5 to <10 yr; N =12, 13) | 5.0 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (≥2 to <5 yr; N = 9, 9) | 17.1 Titers |
| Mouse Brain Derived Vaccine | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type virus (≥5 to <10 yr; N = 12, 13) | 17.0 Titers |
Secondary
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Time frame: Day 42 Post Dose 1
Population: Seroprotection was assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous JE-CV virus PRNT (N = 33, 0) | 33 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous virus Nakayama strain PRNT (N=0,35) | NA Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (All; N = 33, 35) | 33 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nakayama Strain (All; N = 32, 35) | 8 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (All; N = 33, 35) | 27 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥5 to <10 yr; N = 12, 13) | 12 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama strain (≥5 to <10 yr; N =12, 13) | 6 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (≥5 to <10 yr; N = 12, 13) | 12 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥2 to <5 yr; N = 8, 9) | 8 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama strain (≥2 to <5 yr; N = 9, 9) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (≥2 to <5 yr; N = 8, 9) | 2 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥9 mo to <2 yr; N = 13, 13) | 13 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama (≥9 mo to <2 yr; N = 11, 13) | 1 Participants |
| ChimeriVax™-JE | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (≥9 mo to <2 yr; N=13, 13) | 13 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (≥2 to <5 yr; N = 8, 9) | 6 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous JE-CV virus PRNT (N = 33, 0) | NA Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (≥5 to <10 yr; N = 12, 13) | 11 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Homologous virus Nakayama strain PRNT (N=0,35) | 8 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama (≥9 mo to <2 yr; N = 11, 13) | 2 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (All; N = 33, 35) | 33 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥2 to <5 yr; N = 8, 9) | 9 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Nakayama Strain (All; N = 32, 35) | 8 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥9 mo to <2 yr; N = 13, 13) | 12 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (All; N = 33, 35) | 26 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama strain (≥2 to <5 yr; N = 9, 9) | 6 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE-CV Virus (≥5 to <10 yr; N = 12, 13) | 12 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | Wild Type Virus (≥9 mo to <2 yr; N=13, 13) | 9 Participants |
| Mouse Brain Derived Vaccine | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine | JE Virus Nakayama strain (≥5 to <10 yr; N =12, 13) | 0 Participants |