Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in Sou… (NCT01900444) | Clinical Trial Compass
CompletedPhase 3
Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea
South Korea119 participantsStarted 2013-07-11
Plain-language summary
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® .
Who can participate
Age range
2 Years – 4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months before booster vaccination
* Age 2 to 4 years on the day of inclusion
* In good general health at the time of inclusion
* Informed Concent Form signed and dated by parent(s) or another legally acceptable representative(s)
* Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and comply with all study procedures.
Exclusion Criteria:
* Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination
* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
* Receipt of immune globulins, blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection
2
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Timeframe: Day 28 post-booster injection
3
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection
4
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection
5
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection
6
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization
Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection
8
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection