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

Phase 2

Completed

• Conditions: Encephalitis, Tick-borne

• Registration Number: NCT00161889
• Lead Sponsor: Pfizer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study Completion: 2002-08
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-13
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (19)

Hauptstrasse 9; 🇩🇪 Bietigheim-Bissingen, Germany

Marktplatz 33; 🇩🇪 Bad Saulgau, Germany

Salzgasse 11; 🇩🇪 Calw, Germany

Mohrenstrasse 8; 🇩🇪 Coburg, Germany

Bahnhofstrasse 1; 🇩🇪 Elzach, Germany

Peter-Seifert Strasse 5; 🇩🇪 Gersfeld, Germany

Rheinstrasse 1a; 🇩🇪 Ettenheim, Germany

Rastatter Strasse 7; 🇩🇪 Mannheim-Secken, Germany

Schwarzwald Strasse 20; 🇩🇪 Kirchzarten, Germany

Dohmbuehler Strasse 8; 🇩🇪 Nuernberg, Germany

Wilhelmstrasse 25; 🇩🇪 Metzingen, Germany

Wilhelmstrasse 7; 🇩🇪 Offenburg, Germany

Hauptstrasse 11; 🇩🇪 Tegernsee, Germany

Broner Platz 6; 🇩🇪 Weingarten, Germany

Neuschwanstein Strasse 5; 🇩🇪 Augsburg, Germany

Hauptstrasse 240; 🇩🇪 Kehl, Germany

Altoettinger Strasse 3; 🇩🇪 Landsberg, Germany

Berneckstrasse 19; 🇩🇪 Schramberg, Germany

Solothumer Strasse 2; 🇩🇪 Heilbronn, Germany