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

Phase 4

Completed

• Conditions: Encephalitis, Tick-Borne

• Registration Number: NCT00452621
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-26
• Study First Submitted QC: 2007-03-26
• Study First Posted: 2007-03-27
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-22
• Last Update Posted: 2008-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
1) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) with respect to antibody titers in terms of:· percentage

Secondary Outcome Measures

Name	Time	Method
(2) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) in terms of:· percentage of subjects with antibody conce

Trial Locations

Locations (8)

Center 7; 🇩🇪 Aschaffenburg, Germany

Center 2; 🇩🇪 Bobingen, Germany

Center 11; 🇩🇪 Eberbach /Neckar, Germany

Center 4; 🇩🇪 Kaufering, Germany

Center 15; 🇩🇪 Pegnitz, Germany

Center 1; 🇩🇪 Weilheim i. OB, Germany

Center 8; 🇩🇪 Wiesloch, Germany

Center 16; 🇩🇪 Zirndorf, Germany