Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

Double-blind, Randomized, Multicenter Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161798

Enrollment

Unknown

Registered

2005-09-13

Start date

2001-09-30

Completion date

2002-03-31

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

Tick-borne Encephalitis

Brief summary

The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.

Interventions

BIOLOGICALTick-borne encephalitis vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 15 Years

Healthy volunteers

Yes

Inclusion criteria

Male and female children will be eligible for participation in this study if: * they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday); * they are clinically healthy; * their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent; * their legal representative agrees to keep a Volunteer Diary. For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start: * negative pregnancy test at study start; * they agree to employ adequate birth control measures for the duration of the study.

Exclusion criteria

Children will be excluded from participation in this study if they: * have a history of any previous TBE vaccination; * have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA \> 126 VIEU/ml and / or neutralization test \> 1:10); * have a history of allergic reactions, in particular to one of the components of the vaccine; * have received antipyretics within 4 hours prior to the first TBE vaccination; * suffer from a disease that cannot be effectively treated or stabilized; * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions; * suffer from chronic, degenerative and / or inflammatory disease of the central nervous system; * are known to be HIV positive (a special HIV test is not required for the purpose of the study); * suffer from a febrile illness at study entry; * have a history of vaccination against yellow fever and / or Japanese B-encephalitis; * are participating simultaneously in another clinical trial. * if female, are pregnant or breast feeding Volunteers who meet the inclusion /

Countries

Germany

Outcome results

None listed

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