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

NCT ID: NCT00161798

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2002-03-31

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.

Conditions

Tick-borne Encephalitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Tick-borne encephalitis vaccine

Intervention Type: BIOLOGICAL

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.

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Ulrich Behre, MD

Role: PRINCIPAL_INVESTIGATOR

Hauptstrasse 240, 77694 Kehl, Germany

Locations

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

Schwarzwaldstrasse 20

Kirchzarten, , Germany

Altoettingerstrasse 3

Landsberg, , Germany

Rastatter Strasse 7

Mannheim-Secken, , Germany

Wilhelmstrasse 25

Metzingen, , Germany

Heubischer Strasse 39

Neustadt/Cbg, , Germany

Dohmbuehlerstrasse 8

Nuremberg, , Germany

Schwarzwaldstrasse 18

Oberkirch, , Germany

Wilhelmstrasse 7

Offenburg, , Germany

Asternweg 11a

Offenburg, , Germany

Bergstrasse 27

Rottweil, , Germany

Berneckstrasse 19

Schrammberg, , Germany

Hauptstrasse 11

Tegernsee, , Germany

Broner Platz 6

Weingarten, , Germany

Countries

Germany

Other Identifiers

205

Identifier Type: -

Identifier Source: org_study_id