FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years

May 20, 2015 updated by: Pfizer

Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 6 to 16 Years

The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all volunteers who completed two vaccinations in one of the three treatment groups of Baxter study 205 (safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16 years).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

615

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

  • Germany
      • Augsburg, Germany, D-86163
        • Neuschwanstein Strasse 5
      • Bad Saulgau, Germany, D-88348
        • Marktplatz 33
      • Bietigheim-Bissingen, Germany, D-74321
        • Hauptstrasse 9
      • Calw, Germany, D-75365
        • Salzgasse 11
      • Coburg, Germany, D-96450
        • Mohrenstrasse 8
      • Elzach, Germany, D-79215
        • Bahnhofstrasse 1
      • Ettenheim, Germany, D-77955
        • Rheinstrasse 1a
      • Gersfeld, Germany, D-36129
        • Peter-Seifert Strasse 5
      • Heilbronn, Germany, D-74072
        • Solothumer Strasse 2
      • Kehl, Germany, D-77694
        • Hauptstrasse 240
      • Kirchzarten, Germany, D-79199
        • Schwarzwald Strasse 20
      • Landsberg, Germany, D-86899
        • Altoettinger Strasse 3
      • Mannheim-Secken, Germany, 68239
        • Rastatter Strasse 7
      • Metzingen, Germany, D-72555
        • Wilhelmstrasse 25
      • Nuernberg, Germany, D-90449
        • Dohmbuehler Strasse 8
      • Offenburg, Germany, D-77654
        • Wilhelmstrasse 7
      • Schramberg, Germany, D-78713
        • Berneckstrasse 19
      • Tegernsee, Germany, D-83681
        • Hauptstrasse 11
      • Weingarten, Germany, D-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

6 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

All volunteers who participated in Baxter study 205 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:

  • They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 205
  • They and/or their legal guardian understand the nature of the study, agree to its provisions and give written informed consent

Exclusion Criteria:

There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.

Volunteers will be excluded from vaccination and consecutive visits in this study if they:

  • Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)
  • Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 205
  • Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 205
  • Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
  • Have received banked human blood or immunoglobulins within one month of study entry
  • Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 205
  • Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 205
  • Had received an investigational new drug within 6 weeks prior to study start
  • If female and capable of bearing children - have a positive pregnancy test at the first medical examination

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

  • 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

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

February 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

  • 207

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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