NCT01106482

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2009

Geographic Reach
1 country

10 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

April 12, 2010

Last Update Submit

December 7, 2011

Conditions

Tick Borne Encephalitis (TBE)

Keywords

TBETick Borne Encephalitis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Study Arms (4)

Arm 1

ACTIVE COMPARATOR
Other: Serology blood draw

Arm 2

ACTIVE COMPARATOR
Other: Serology blood draw

Arm 3

ACTIVE COMPARATOR
Other: Serology blood draw

Arm 4

ACTIVE COMPARATOR
Other: Serology blood draw

Interventions

Serology blood drawOTHER

Blood draw only, no vaccine

Arm 1Arm 2Arm 3Arm 4

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Winkelhoferstr. 3

Ehingen, 89584, Germany

Location

Fuggerplatz 1

Kaufering, 86916, Germany

Location

Hauptstrasse 240

Kehl, 77694, Germany

Location

Bismarckstr. 3

Ludwigsburg, 71634, Germany

Location

Am Marktplatz 8

Oberkirch, 77704, Germany

Location

Großbottwarer Str. 47

Oberstenfeld, 71720, Germany

Location

Wilhelmstr. 7

Offenburg, 77654, Germany

Location

Stuttgarter Str. 74

Stuttgart, 70469, Germany

Location

Martin-Niemöller-Str. 2

Traunreut, 83301, Germany

Location

Murnauer Str. 3

Weilheim, 82362, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25728316DERIVED

MeSH Terms

Conditions

Encephalitis, Tick-Borne

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 20, 2010

Study Start

May 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

December 8, 2011

Record last verified: 2011-12

Locations

DE(10)