FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years

Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 1 to 6 Years

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161850

Enrollment

615

Registered

2005-09-13

Start date

2002-02-28

Completion date

2002-08-31

Last updated

2015-05-21

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

Conditions

Encephalitis, Tick-borne

Brief summary

The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).

Interventions

BIOLOGICALTick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

1 Years to 6 Years

Healthy volunteers

Yes

Inclusion criteria

All volunteers who participated in Baxter study 199 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if: * They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 199 * Written informed consent from the legal guardian is available.

Exclusion criteria

There are no specific

Countries

Austria, Germany

Outcome results

None listed

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