Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old C… (NCT04817917) | Clinical Trial Compass
UnknownPhase 4
Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province
China712 participantsStarted 2021-03-01
Plain-language summary
This study is to evaluate the seroprevalence of neutralizing antibodies against Japanese encephalitis (JE) virus in children aged 6 years who were previously administered with 5 different immunization strategies by JE attenuated live vaccine (JEV-L) or/and inactivated vaccine (JEV-I). The secondary objective is to evaluate the immunogenicity of the booster dose of JEV-I at 6 years old for those previously immunized with 3 doses of JEV-I or those sequential administered with 1 dose of JEV-L and another dose of JEV-I.
Who can participate
Age range
72 Months – 75 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:
* Participants aged ≥ 72 months to \< 75 months.
* Participants have completed routine immunization schedules in time.
* Participants are healthy native residents.
* Parents/guardians can understand the protocol requirements, provide informed consent, accept all scheduled visits, and comply with all trial procedures.
Exclusion Criteria:
* History of neurological diseases or related symptoms.
* An acute illness with fever (temperature ≥ 37.1℃) or any acute onset of chronic diseases.
* Known impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin in the past 3 months.
* Known allergy to any constituent of the vaccine.
* Have been injected with other vaccines or any clinical trial drugs in the past 4 weeks.
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
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
Proportions of seropositivity of neutralizing antibodies against JE at the age of 6
Timeframe: At the age of 6. Test immediately after enrollment by a dose of blood sample.
2
Geometric Mean Titers (GMTs) or Median antibody titers for children aged 6 years
Timeframe: At the age of 6. Test immediately after enrollment by a dose of blood sample.
Trial details
NCT IDNCT04817917
SponsorZhejiang Provincial Center for Disease Control and Prevention