CompletedPhase 3

Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV

Philippines454 participantsStarted 2010-08-25

Plain-language summary

The aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in participants previously vaccinated with JE-CV vaccine. Objectives: * To describe JE immune status before and after JE-CV vaccination in subjects previously vaccinated with JE-CV vaccine * To describe the immune status before and after JE-CV vaccination in JE-naïve control subjects. * To describe the safety (in terms of solicited and unsolicited adverse events) of a single dose of JE-CV vaccine up to 6 months after the last vaccination. * To describe all related serious adverse events (SAEs) and related deaths from 6 months to 5 years after vaccination in JE-CV-primed subjects.

Who can participate

Age range

36 Months – 42 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

. Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw (for Groups 1 and 2)
. Febrile illness (temperature ≥38.0°C \[≥100.4°F\]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination (for all participants)

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

Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV

Timeframe: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination

Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine

Timeframe: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination

Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV

Timeframe: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination

Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV

Timeframe: Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination

Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV

Timeframe: Day 0 (pre-vaccination)

Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV

Timeframe: Day 0 (pre-vaccination) and Days 7 and 28, and Year 1, 2, 3, 4, and 5 post-vaccination

Trial details

NCT IDNCT01190228

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10-29

Results submitted2017-08-31

View on ClinicalTrials.gov More Japanese Encephalitis trials

Plain-language summary

Who can participate

Age range

36 Months – 42 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

. Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw (for Groups 1 and 2)
. Febrile illness (temperature ≥38.0°C \[≥100.4°F\]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination (for all participants)