The aim of this study is to further characterize the safety profile of IMOJEV®. Primary Objective: * To describe serious adverse events (SAEs, including adverse events of special interest \[AESIs\]) up to 60 days after administration of one dose of IMOJEV®. Secondary Objective: * To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.
Participants aged 1 year to less than 5 years will be randomized to receive one injection of IMOJEV® either as a primary vaccination or as a booster. Safety data will be collected for 60 days after IMOJEV® vaccination. The duration of each subject's participation in the trial will be 60 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
10,000
0.5 mL, Subcutaneous.
0.5 mL, Subcutaneous.
Unnamed facility
Bangkok, Thailand
Unnamed facility
Bangkok, Thailand
Unnamed facility
Chiang Mai, Thailand
Unnamed facility
Khon Kaen, Thailand
Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®
Time frame: 30 minutes post-vaccination up to Day 60 post-vaccination
Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®
Time frame: Day O up to Day 60 post-vaccination
Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®
Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure.
Time frame: Day O up to Day 60 post-vaccination
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Unnamed facility
Nakornnayok, Thailand
Unnamed facility
Nonthaburi, Thailand
Unnamed facility
Pathum Thani, Thailand
Unnamed facility
Songkhla, Thailand