Japanese Encephalitis Clinical Trial
Official title:
Randomised, Double-blind, Phase II Evaluation of the Safety and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)
The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the
co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®.
Objectives:
Safety:
- Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE
administered concurrently, one month before or one month after STAMARIL® to adult
volunteers (≥ 18 to ≤ 55 years) without prior Japanese encephalitis (JE) or yellow
fever (YF) vaccination.
Immunogenicity:
- Obtain data on the antibody response to a single, fixed dose of ChimeriVax™-JE
administered concurrently, one month before or one month after STAMARIL® to adult
volunteers without prior JE (or YF) vaccination.
- Assess the durability of the immune response in adult volunteers 6 months after
administration of ChimeriVax™-JE and STAMARIL®.
All participants will receive two injections, one to each arm on Days 0 and 30, respectively. Immunogenicity will be tested on Days 0, 15, 30, 45, and 60, and at Month 6. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03282370 -
Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam
|
Phase 3 | |
| Recruiting |
NCT05568953 -
An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity
|
Phase 2 | |
| Completed |
NCT00776230 -
Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
|
Phase 3 | |
| Completed |
NCT00594958 -
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
| Completed |
NCT00595790 -
Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
| Completed |
NCT00596271 -
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
|
Phase 3 | |
| Completed |
NCT00604708 -
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
| Not yet recruiting |
NCT01954810 -
Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children
|
Phase 4 | |
| Completed |
NCT01246479 -
Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
|
Phase 3 | |
| Completed |
NCT00595270 -
Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
| Completed |
NCT00605085 -
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
| Completed |
NCT00596102 -
Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
| Completed |
NCT00314132 -
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
|
Phase 3 | |
| Active, not recruiting |
NCT01981967 -
Post-licensure Safety Study of IMOJEV® in Thailand
|
Phase 4 | |
| Completed |
NCT01466387 -
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
|
Phase 3 | |
| Completed |
NCT00314145 -
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
|
Phase 3 | |
| Completed |
NCT00981630 -
Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine
|
Phase 2 | |
| Completed |
NCT01567865 -
Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
|
Phase 4 | |
| Completed |
NCT01656200 -
A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
|
Phase 4 | |
| Unknown status |
NCT01163123 -
Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan
|
N/A |