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

May 20, 2015 updated by: Pfizer

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wels, Austria, 4600
        • Grieskirchner Strasse 17
  • Germany
      • Augsburg, Germany, 86163
        • Neuschwansteinstrasse 5
      • Bad Saulgau, Germany, 88348
        • Marktplatz 3
      • Bietigheim-Bissingen, Germany, 74321
        • Hauptstrasse 9
      • Calw, Germany, 75365
        • Salzgasse 11
      • Coburg, Germany, 96450
        • Mohrenstrasse 8
      • Elzach, Germany, 79215
        • Bahnhofstrasse 1
      • Ettenheim, Germany, 77955
        • Rheinstrasse 13
      • Gersfeld, Germany, 36129
        • Peter-Seifert-Strasse 5
      • Heilbronn, Germany, 74072
        • Solothurner Strasse 2
      • Kehl, Germany, 77694
        • Hauptstrasse 240
      • Kirchzarten, Germany, 79199
        • Schwarzwaldstrasse 20
      • Landsberg, Germany, 86899
        • Altoettingerstrasse 3
      • Mannheim-Secken, Germany, 68239
        • Rastatter Strasse 7
      • Neustadt/Cbg, Germany, 96465
        • Heubischer Strasse 39
      • Nürnberg, Germany, 90449
        • Dohmbuehlerstrasse 8
      • Nürnberg, Germany, 90473
        • Glogauer Strasse 15
      • Oberndorf / Neckar, Germany, 78727
        • Tuchbergstrasse 2
      • Offenburg, Germany, 77656
        • Asternweg 11a
      • Offenburg, Germany, 77654
        • Wilhelmstrasse 7
      • Schrammberg, Germany, 78713
        • Berneckstrasse 19
      • Tegernsee, Germany, 83681
        • Hauptstrasse 11
      • Weingarten, Germany, 88250
        • Broner Platz 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion

August 1, 2002

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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