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

Brief Title

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

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.

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

September 2001

Completion Date

March 2002

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;

          -  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.

Gender

All

Ages

6 Years - 15 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ulrich Behre, MD, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00161798

Organization ID

Study Sponsor

Pfizer

Study Sponsor

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

Verification Date

May 2015