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Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers

NCT01188343 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2014-08-15

Study results available
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Summary

This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at separate visits 6 weeks apart in toddlers aged 12 to 18 months.

Primary objective:

* To demonstrate the non-inferiority of the antibody responses in terms of seroconversion of the concomitant administration of JE-CV and MMR compared to the antibody responses after the single administration of JE-CV and MMR vaccine.

Secondary objectives:

* To describe the immune response to JE CV and MMR before and after one dose of JE CV and MMR vaccine, respectively.
* To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a 6-week interval and the safety of the concomitant administration of JE-CV and MMR vaccine in all subjects up to 6 months after last vaccination.

Conditions

Interventions

BIOLOGICAL

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

0.5 mL each; Subcutaneous (SC)

BIOLOGICAL

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

0.5 mL each, Subcutaneous (SC)

BIOLOGICAL

Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus

0.5 mL each, subcutaneous (SC)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT01188343 on ClinicalTrials.gov