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

Phase 2

Completed

• Conditions: Tick-borne Encephalitis

• Registration Number: NCT00161798
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Study Completion: 2002-03
• 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: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (23)

Neuschwansteinstrasse 5; 🇩🇪 Augsburg, Germany

Marktplatz 33; 🇩🇪 Bad Saulgau, Germany

Hauptstrasse 9; 🇩🇪 Bietigheim-Bissingen, Germany

Salzgasse 11; 🇩🇪 Calw, Germany

Mohrenstrasse 8; 🇩🇪 Coburg, Germany

Bahnhofstrasse 1; 🇩🇪 Elzach, Germany

Rheinstrasse 13; 🇩🇪 Ettenheim, Germany

Peter-Seifert Strasse 5; 🇩🇪 Gersfeld, Germany

Solothurner Strasse 2; 🇩🇪 Heilbronn, Germany

Hauptstraße 240; 🇩🇪 Kehl, Germany

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