The aim of this study was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose. Primary objective: * To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a booster dose of IMOJEV administered at least 12 months after primary vaccination with IMOJEV. Exploratory objectives: * To describe the safety profile of a booster dose of IMOJEV® .
Participants who previously participated in Study JEC12 (NCT01396512) and were primed with IMOJEV received a booster dose of IMOJEV at least 12 months after the primary dose. Participants were assessed for immune response before and on Day 28 after the booster dose and were monitored for safety through Day 28 post-vaccination for non-serious adverse events (AEs) and up to 6 months post-vaccination for serious AEs The duration of each participant's participation in the study was approximately 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
119
0.5 mL, Subcutaneous
Investigational Site 004
Gyeonggi-do, South Korea
Investigational Site 010
Gyeonggi-do, South Korea
Investigational Site 001
Seoul, South Korea
Investigational Site 005
Seoul, South Korea
Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.
Time frame: Day 28 post-booster injection
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50 test.
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50.
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
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Investigational Site 006
Seoul, South Korea
Investigational Site 008
Seoul, South Korea
Investigational Site 009
Seoul, South Korea
Investigational Site 007
Wŏnju, South Korea
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.
Time frame: Day 28 post-booster injection
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50.
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
JE virus neutralizing antibodies were measured using PRNT50.
Time frame: Day 0 (pre-booster) and Day 28 post-booster injection