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.

Pfizer23 sites in 1 countrySeptember 2001

ConditionsTick-borne Encephalitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Tick-borne Encephalitis
Sponsor: Pfizer
Locations: 23
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2001

End Date

March 2002

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

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;