Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand

NCT01981967 Phase 4 COMPLETED Results posted

The aim of this study is to further characterize the safety profile of IMOJEV®. Primary Objective: * To describe serious adverse events (SAEs, including adverse events of special interest \[AESIs\]) up to 60 days after administration of one dose of IMOJEV®. Secondary Objective: * To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 4
Status	COMPLETED
Enrolment	10000
Start date	2013-11
Completion	2015-10

Conditions

• Japanese Encephalitis

Interventions

• IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
• IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

Primary outcomes

• Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® — 30 minutes post-vaccination up to Day 60 post-vaccination
• Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® — Day O up to Day 60 post-vaccination

Countries

Thailand