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Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years

NCT ID: NCT00452621

Last Updated: 2008-04-23

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

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Brief Summary

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blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children

Detailed Description

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Conditions

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Encephalitis, Tick-Borne

Keywords

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blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children TBE

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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blood draw

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers of both sexes aged \>1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 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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Novartis Vaccines

Role: STUDY_CHAIR

Novartis

Locations

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Center 7

Aschaffenburg, , Germany

Site Status

Center 2

Bobingen, , Germany

Site Status

Center 11

Eberbach /Neckar, , Germany

Site Status

Center 4

Kaufering, , Germany

Site Status

Center 15

Pegnitz, , Germany

Site Status

Center 1

Weilheim I. OB, , Germany

Site Status

Center 8

Wiesloch, , Germany

Site Status

Center 16

Zirndorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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V48P4E3

Identifier Type: -

Identifier Source: org_study_id