Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Jap… (NCT06825312) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
China600 participantsStarted 2023-11-11
Plain-language summary
The main objective of this study is to evaluate the persistence of Japanese encephalitis antibodies in participants at the age of 6, after they have followed different Japanese encephalitis vaccination schedules. Furthermore, the study will assess the immunogenicity and antibody persistence of primary immunization across different Japanese encephalitis vaccination schedules, as well as the immunogenicity following booster immunizations within these schedules. The safety of each vaccine dose will also be evaluated.
Who can participate
Age range
8 Months – 8 Months
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:
* Healthy children aged 8 months who are permanent residents of the study area.
* Legal guardians can understand the requirements and processes of the study, provide written informed consent, and comply with all procedures as required by the clinical research protocol.
* Able to receive the full course of Japanese encephalitis vaccinations according to the immunization strategy in the research protocol, including receiving the primary immunization at 8 months of age and the booster immunizations at 24 months of age and 6 years of age.
Exclusion Criteria:
* Unable to finish the full course of primary and booster immunizations at the study area, and unable to fulfill the follow-up visits prescribed in the protocol.
* Non-compliance with the vaccination strategy for each group, as stated in the protocol, regarding Japanese encephalitis vaccines with proper doses and varieties.
* Allergic to any component of the study vaccine or having a history of allergic reactions to any vaccines.
* Having a history of symptoms or signs of neurological diseases or other contraindications for Japanese encephalitis vaccine vaccination.
* Having used immunosuppressants or blood products following birth.
* Receiving other vaccines simultaneously while receiving the Japanese encephalitis vaccine of this project.
* Any conditions that may interfere with the evaluation of the study, as deemed by the researcher.
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 Testing Seropositive for Japanese Encephalitis Neutralizing Antibodies
Timeframe: 4 years after the booster vaccination at 24 months of age