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An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

NCT ID: NCT01106482

Last Updated: 2011-12-08

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

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-05-31

Brief Summary

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This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine

Detailed Description

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Conditions

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Tick Borne Encephalitis (TBE)

Keywords

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TBE Tick Borne Encephalitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

Serology blood draw

Intervention Type OTHER

Blood draw only, no vaccine

Arm 2

Group Type ACTIVE_COMPARATOR

Serology blood draw

Intervention Type OTHER

Blood draw only, no vaccine

Arm 3

Group Type ACTIVE_COMPARATOR

Serology blood draw

Intervention Type OTHER

Blood draw only, no vaccine

Arm 4

Group Type ACTIVE_COMPARATOR

Serology blood draw

Intervention Type OTHER

Blood draw only, no vaccine

Interventions

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Serology blood draw

Blood draw only, no vaccine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian informed consent

Exclusion Criteria

* Subjects who did not receive complete schedule of primary vaccination in the parent study
* Subjects enrolled in other investigational studies at the same time and within the last three months
* Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Winkelhoferstr. 3

Ehingen, , Germany

Site Status

Fuggerplatz 1

Kaufering, , Germany

Site Status

Hauptstrasse 240

Kehl, , Germany

Site Status

Bismarckstr. 3

Ludwigsburg, , Germany

Site Status

Am Marktplatz 8

Oberkirch, , Germany

Site Status

Großbottwarer Str. 47

Oberstenfeld, , Germany

Site Status

Wilhelmstr. 7

Offenburg, , Germany

Site Status

Stuttgarter Str. 74

Stuttgart, , Germany

Site Status

Martin-Niemöller-Str. 2

Traunreut, , Germany

Site Status

Murnauer Str. 3

Weilheim, , Germany

Site Status

Countries

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Germany

References

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Wittermann C, Izu A, Petri E, Gniel D, Fragapane E. Five year follow-up after primary vaccination against tick-borne encephalitis in children. Vaccine. 2015 Apr 8;33(15):1824-9. doi: 10.1016/j.vaccine.2015.02.038. Epub 2015 Feb 26.

Reference Type DERIVED
PMID: 25728316 (View on PubMed)

Other Identifiers

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M48P3E1

Identifier Type: -

Identifier Source: org_study_id