NCT01981967

Post-licensure Safety Study of IMOJEV® in Thailand

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10,000 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 4 Years
• Healthy volunteers: Accepted

Summary

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®.

Detailed description

Participants aged 1 year to less than 5 years will be randomized to receive one injection of IMOJEV® either as a primary vaccination or as a booster. Safety data will be collected for 60 days after IMOJEV® vaccination. The duration of each subject's participation in the trial will be 60 days.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine	0.5 mL, Subcutaneous.
BIOLOGICAL	IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine	0.5 mL, Subcutaneous.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-04-01
• Completion: 2015-10-01
• First posted: 2013-11-13
• Last updated: 2016-05-04
• Results posted: 2016-05-04

Locations

8 sites across 1 country: Thailand