Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

A Phase IV, Randomized, Controlled, Single-Blind, Multi-Center Study in Children to Evaluate the Safety, Tolerability and Immunogenicity of Two TBE Vaccines Administered According to Two Different Schedules.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00311441

Enrollment

300

Registered

2006-04-06

Start date

2005-03-31

Completion date

Unknown

Last updated

2008-03-17

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

Conditions

Encephalitis, Tick-Borne

Keywords

TBE, children, vaccine

Brief summary

The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.

Interventions

BIOLOGICALTick-Borne Encephalitis vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

1 Years to 10 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female children, 1 to 10 years of age.

Exclusion criteria

* Subjects with documented evidence of TBE * Subjects, who have been previously vaccinated against TBE

Design outcomes

Primary

Measure	Time frame
Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.	—

Secondary

Measure	Time frame
Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever	—

Countries

Germany

Outcome results

None listed

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