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Long-term Follow-up of Imojev Immunogenicity in Toddlers
NCT01001988Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2009
- Primary completion
- Oct 2013
- Countries
- 2
- Sponsor
- Sanofi
- Modality
- Live Attenuated Vaccines
- Conditions
- Japanese encephalitis (JE)
01
Overview
Phase 3, open-label, single-arm trial of japanese encephalitis chimeric virus vaccine in Japanese encephalitis (JE), sponsored by Sanofi. Primary endpoints: Percentage of Participants With Japanese Encephalitis Seroprotection at Year 5 and Geometric Mean Titers of Japanese Encephalitis Virus Antibodies at Year 5. Started Aug 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Study group
Participants who received a single dose of JE-CV in Study JEC02.
03
Who it enrols
Participants who received a single dose of JE-CV in the JEC02 trial at 12-18 months of age.
04
Endpoints
Primary
Percentage of Participants With Japanese Encephalitis Seroprotection
Geometric Mean Titers of Japanese Encephalitis Virus Antibodies
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