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

Phase 4CompletedNCT00452621

Novartis235 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

235

Conditions

Encephalitis, Tick-Borne

Interventions

blood drawPROCEDURE

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

Center 7

Aschaffenburg, Germany

Center 2

Bobingen, Germany

Center 11

Eberbach /Neckar, Germany

Center 4

Kaufering, Germany

Outcomes

Primary Outcomes

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 Outcomes

(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

Data from ClinicalTrials.gov

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