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

Phase 4

Completed

• Conditions: Tick Borne Encephalitis (TBE)
• Interventions: Other: Serology blood draw

• Registration Number: NCT01106482
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4	Serology blood draw	-
Arm 1	Serology blood draw	-
Arm 2	Serology blood draw	-
Arm 3	Serology blood draw	-

Primary Outcome Measures

Name	Time	Method
Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination	3 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination	4 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination	5 years after vaccination

Secondary Outcome Measures

Name	Time	Method
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination	3 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination	4 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination	5 years after vaccination

Trial Locations

Locations (10)

Martin-Niemöller-Str. 2; 🇩🇪 Traunreut, Germany

Stuttgarter Str. 74; 🇩🇪 Stuttgart, Germany

Wilhelmstr. 7; 🇩🇪 Offenburg, Germany

Großbottwarer Str. 47; 🇩🇪 Oberstenfeld, Germany

Murnauer Str. 3; 🇩🇪 Weilheim, Germany

Winkelhoferstr. 3; 🇩🇪 Ehingen, Germany

Fuggerplatz 1; 🇩🇪 Kaufering, Germany

Bismarckstr. 3; 🇩🇪 Ludwigsburg, Germany

Hauptstrasse 240; 🇩🇪 Kehl, Germany

Am Marktplatz 8; 🇩🇪 Oberkirch, Germany