Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

NCT00595465 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2014-05-16

Study results available
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Summary

The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Conditions

  • Japanese Encephalitis

Interventions

BIOLOGICAL

Japanese Encephalitis purified inactivated vaccine

IC51 6 mcg i.m. injection on Day 0 and Day 28

Sponsors & Collaborators

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Nicole Haas · Valneva Austria GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-02-29
Completion
2008-06-30

Countries

  • Austria
  • Germany

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 NCT00595465 on ClinicalTrials.gov