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Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

NCT01047839 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-06-30

Study results available
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Summary

The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

Conditions

Interventions

BIOLOGICAL

IC51

0.25 ml, 2 i.m. vaccinations at Day 0 and 28

BIOLOGICAL

IC51

0.5 ml, 2 i.m. vaccinations at Day 0 and 28

BIOLOGICAL

IC51

0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Sponsors & Collaborators

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Andrea Ayad, Dr. · Valneva Austria GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States
  • Australia
  • Denmark
  • Germany
  • Sweden

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 NCT01047839 on ClinicalTrials.gov