Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

Brief Title

Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

Official Title

Double-blind, Randomized, Multicenter Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

Brief Summary

      The purpose of this study is to investigate the safety and immunogenicity of three different
      concentrations of a TBE vaccine in healthy children aged 1 to 6 years.

Study Phase

Phase 2

Study Type

Interventional

Condition

Tick-borne Encephalitis

Intervention

Tick-borne Encephalitis Vaccine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Start Date

March 2002

Completion Date

August 2002

Eligibility Criteria

        Inclusion Criteria:

        Male and female children will be eligible for participation in this study if:

          -  they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th
             birthday) old;

          -  they are clinically healthy;

          -  their legal representative understands the nature of the study, agrees to its
             provisions and gives written informed consent;

          -  their legal representative agrees to keep a Volunteer Diary.

        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.

Gender

All

Ages

1 Year - 5 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ulrich Behre, MD, ,

Location Countries

Austria

Location Countries

Austria

Administrative Informations

NCT ID

NCT00161772

Organization ID

Study Sponsor

Pfizer

Study Sponsor

Ulrich Behre, MD, Principal Investigator, Hauptstrasse 240, 77694 Kehl, Germany

Verification Date

May 2015