MedTrace Logo

Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

NCT02492165 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2022-03-28

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity, reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data from other Asian pediatric populations.

Primary objective:

\- To describe the safety profile of a single dose of IMOJEV®.

Secondary objectives:

* To evaluate the immune response to JE 28 days after the administration of a single dose of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.

Conditions

  • Japanese Encephalitis

Interventions

BIOLOGICAL

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

0.5 mL, Subcutaneous

BIOLOGICAL

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

0.5 mL, Subcutaneous

BIOLOGICAL

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

0.5 mL, Subcutaneous

BIOLOGICAL

Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

0.5 mL, Subcutaneous

Sponsors & Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • 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
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-03-31
Completion
2016-06-30

Countries

  • Vietnam

Study Locations

More Related Trials

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 NCT02492165 on ClinicalTrials.gov