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Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population

NCT01041573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1869

Last updated 2021-07-27

Study results available
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Summary

The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.

Conditions

Interventions

BIOLOGICAL

IC51 Japanese Encephalitis

6 mcg or 3 mcg im. at day 0 and day 28

BIOLOGICAL

Havrix®720

0.5 ml im. at day 0 and month 7

BIOLOGICAL

Prevnar

0.5 ml im. at day 0 and day 56 and month 7

Sponsors & Collaborators

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Vera Kadlecek · Valneva Austria GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-02-28
Completion
2011-07-31

Countries

  • Philippines

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 NCT01041573 on ClinicalTrials.gov