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Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers

NCT01396512 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2014-04-25

Study results available
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Summary

The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine \[CD.JEVAX™\]) after a single dose vaccination to support product registration.

Primary Objective:

* To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine.

Secondary Objectives:

* To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.
* To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.

Conditions

  • Japanese Encephalitis
  • Japanese Encephalitis Virus Disease

Interventions

BIOLOGICAL

Live attenuated Japanese encephalitis chimeric virus vaccine

0.5 mL, Subcutaneous

BIOLOGICAL

Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)

0.5 mL, Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-03-31
Completion
2013-06-30

Countries

  • South Korea

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 NCT01396512 on ClinicalTrials.gov