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Post-licensure Safety Study of IMOJEV® in Thailand

NCT01981967 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2016-05-04

Study results available
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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®.

Conditions

  • Japanese Encephalitis

Interventions

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.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-04-30
Completion
2015-10-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01981967 on ClinicalTrials.gov