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 range36 Months – 42 Months

SexALL

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)

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

Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV

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 range36 Months – 42 Months

SexALL

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)