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

A Phase IV, Open-label, Multi-center Follow-up Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01106482

Enrollment

126

Registered

2010-04-20

Start date

2009-05-31

Completion date

2011-05-31

Last updated

2011-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tick Borne Encephalitis (TBE)

Keywords

TBE, Tick Borne Encephalitis

Brief summary

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

Interventions

OTHERSerology blood draw

Blood draw only, no vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 14 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026