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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
250
0.5 mL, Subcutaneous
0.5 mL, Subcutaneous
0.5 mL, Subcutaneous
0.5 mL, Subcutaneous
Preventive Medicine Centre of Hoa Binh Province
Hòa Bình, Vietnam
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
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
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
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
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