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JE-CV and MMR Concomitant Administration in Toddlers
NCT01188343Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2010
- Primary completion
- Jul 2012
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Live Attenuated Vaccines
- Conditions
- Japanese encephalitis (JE)
01
Overview
Phase 3, randomised, open-label trial of japanese encephalitis chimeric virus vaccine in Japanese encephalitis (JE) (3 arms), sponsored by Sanofi. Primary endpoint: Percentage of Participants With Seroconversion to Vaccine Antigens at Day 42. Started Aug 2010; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Group 1
JE-CV (Day 0) -> MMR (Day 42)
Group 2
MMR (Day 0) -> JE-CV (Day 42)
Group 3
JE-CV + MMR (Day 0)
03
Who it enrols
Healthy toddlers aged 12-18 months born at full term without prior vaccination for JE or MMR.
04
Endpoints
Primary
Percentage of Participants With Seroconversion to Vaccine Antigens
Secondary
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens
Number of Participants With Seroprotection to JE-CV and MMR Antigens
Geometric Mean Titers of Antibodies to Vaccine Antigens
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
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