NCT00452621

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
Last Updated

April 23, 2008

Status Verified

April 1, 2008

First QC Date

March 26, 2007

Last Update Submit

April 22, 2008

Conditions

Encephalitis, Tick-Borne

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • (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

Interventions

blood drawPROCEDURE

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Center 7

Aschaffenburg, 63741, Germany

Location

Center 2

Bobingen, 86399, Germany

Location

Center 11

Eberbach /Neckar, 69412, Germany

Location

Center 4

Kaufering, 86916, Germany

Location

Center 15

Pegnitz, 91257, Germany

Location

Center 1

Weilheim I. OB, 82362, Germany

Location

Center 8

Wiesloch, 69168, Germany

Location

Center 16

Zirndorf, 90513, Germany

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesTick-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Novartis Vaccines

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 27, 2007

Study Start

February 1, 2007

Last Updated

April 23, 2008

Record last verified: 2008-04

Locations

DE(8)