Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

NCT ID: NCT00311441

Last Updated: 2008-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

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The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.

Detailed Description

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Conditions

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Encephalitis, Tick-Borne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Tick-Borne Encephalitis vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female children, 1 to 10 years of age.

Exclusion Criteria

* Subjects with documented evidence of TBE
* Subjects, who have been previously vaccinated against TBE
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Drug Information Services

Role: STUDY_DIRECTOR

Novartis Vaccines & Diagnostics

Locations

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Weilheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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911

Identifier Type: -

Identifier Source: secondary_id

M48P3

Identifier Type: -

Identifier Source: org_study_id

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