Post-licensure Safety Study of IMOJEV® in Thailand

Status Active, not recruiting

Clinical Trial 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®.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01981967
Study type	Interventional
Source	Sanofi
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	November 2013
Completion date	June 2016

View Details

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