CompletedPhase 4

Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster Dose

561 participantsStarted 2015-07-30

Plain-language summary

This study aims to understand the persistence of the Japanese encephalitis (JE) antibody response in previously vaccinated children. The proposed study will enrol Bangladeshi children who had previously participated in a lot to lot consistency study (JEV05; NCT01567865) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).

Who can participate

Age range

43 Months – 51 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: * Participant in JEV05 study (NCT01567865) and received one dose of CD-JEV. * Resides in the Matlab or Mirpur study area. * At least one parent or guardian willing to provide written informed consent. Exclusion Criteria: * Received a second dose of Japanese encephalitis vaccine within the past three years. * Received immunoglobulins and/or any blood products within 90 days prior to enrollment. * Been diagnosed with a primary or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection within the past three years.

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

Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV

Timeframe: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)

Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV

Timeframe: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)

Trial details

NCT IDNCT02514746

SponsorPATH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12-15

Results submitted2020-09-17

View on ClinicalTrials.gov More Encephalitis, Japanese trials

Plain-language summary

Who can participate

Age range

43 Months – 51 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.

What they're measuring

Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV

Timeframe: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)

Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV

Timeframe: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)