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A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX

NCT00314145 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2012-12-06

Study results available
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Summary

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.

Conditions

  • Japanese Encephalitis

Interventions

BIOLOGICAL

ChimeriVax™-JE

0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)

BIOLOGICAL

JE-VAX®

0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)

Sponsors & Collaborators

Principal Investigators

  • Luis Angles, M.D. · Heart of America Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-06-30
Completion
2006-11-30

Countries

  • United States
  • Australia

Study Locations

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Entities

Companies

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 NCT00314145 on ClinicalTrials.gov