Japanese Encephalitis Clinical Trial
Official title:
A Controlled Study of the Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Comparison With SA14-14-2 Vaccine in Infants and Toddlers in Thailand
The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric
virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in
infants and toddlers.
Primary Objective:
- To demonstrate the non-inferiority of the antibody response 28 days after vaccine
administration of one dose of JE CV (administered on Day 0) compared to the antibody
response after one dose of the SA14-14-2 control vaccine (administered on Day 0).
Secondary Objectives:
- To describe the immune response to JE in both vaccine groups in JE-CV virus and
SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2
vaccine
- To describe the safety profile in all vaccinated subjects up to 28 days and all serious
adverse events (SAEs) up to 6 months after vaccination.
- To describe only related SAEs and all death from 6 month to 12-month follow-up.
All participants will receive one injection of their randomized vaccine on Day 0. Follow-up will continue for 12 months after vaccination. ;
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 |
NCT00596271 -
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
|
Phase 3 | |
| Completed |
NCT00595790 -
Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51
|
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 |
NCT00314132 -
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
|
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 |
NCT00595270 -
Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
|
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 |