Clinical Trials Logo

Clinical Trial Summary

The aim of this study was to document the immunogenicity and safety of a booster dose of IMOJEV administered at least 12 months after the primary dose. Primary objective: - To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a booster dose of IMOJEV administered at least 12 months after primary vaccination with IMOJEV. Exploratory objectives: - To describe the safety profile of a booster dose of IMOJEV® .


Clinical Trial Description

Participants who previously participated in Study JEC12 (NCT01396512) and were primed with IMOJEV received a booster dose of IMOJEV at least 12 months after the primary dose. Participants were assessed for immune response before and on Day 28 after the booster dose and were monitored for safety through Day 28 post-vaccination for non-serious adverse events (AEs) and up to 6 months post-vaccination for serious AEs The duration of each participant's participation in the study was approximately 6 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01900444
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date July 11, 2013
Completion date March 11, 2014

See also
  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 NCT00604708 - Immunogenicity 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 NCT00595790 - Rapid Immunization 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 NCT00595270 - Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 Phase 3
Completed NCT00596102 - Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51 Phase 3
Completed NCT00605085 - Safety and Tolerability 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 NCT01656200 - A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2 Phase 4
Completed NCT01567865 - Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine Phase 4
Unknown status NCT01163123 - Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan N/A