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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Tick-borne Encephalitis

Treatments

Biological: Tick-borne encephalitis vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00161798

205

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 15 years old

Volunteers

Accepts Healthy Volunteers

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 / exclusion criteria, but have a febrile illness (body temperature >= 38° C, measured orally) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.