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

NCT ID: NCT00161772

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2002-08-31

Brief Summary

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.

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 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 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

Grieskirchner Strasse 17

Wels, , Austria

Neuschwansteinstrasse 5

Augsburg, , Germany

Marktplatz 3

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

Heubischer Strasse 39

Neustadt/Cbg, , Germany

Dohmbuehlerstrasse 8

Nuremberg, , Germany

Glogauer Strasse 15

Nuremberg, , Germany

Tuchbergstrasse 2

Oberndorf / Neckar, , Germany

Wilhelmstrasse 7

Offenburg, , Germany

Asternweg 11a

Offenburg, , Germany

Berneckstrasse 19

Schrammberg, , Germany

Hauptstrasse 11

Tegernsee, , Germany

Broner Platz 6

Weingarten, , Germany

Countries

Austria; Germany

Other Identifiers

199

Identifier Type: -

Identifier Source: org_study_id