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

NCT ID: NCT00161889

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 615 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2002-08-31

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).

Conditions

Encephalitis, Tick-borne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Interventions

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Baxter BioScience Investigator

Role: PRINCIPAL_INVESTIGATOR

Baxter Healthcare Corporation

Locations

Neuschwanstein Strasse 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 1a

Ettenheim, , Germany

Peter-Seifert Strasse 5

Gersfeld, , Germany

Solothumer Strasse 2

Heilbronn, , Germany

Hauptstrasse 240

Kehl, , Germany

Schwarzwald Strasse 20

Kirchzarten, , Germany

Altoettinger Strasse 3

Landsberg, , Germany

Rastatter Strasse 7

Mannheim-Secken, , Germany

Wilhelmstrasse 25

Metzingen, , Germany

Dohmbuehler Strasse 8

Nuremberg, , Germany

Wilhelmstrasse 7

Offenburg, , Germany

Berneckstrasse 19

Schramberg, , Germany

Hauptstrasse 11

Tegernsee, , Germany

Broner Platz 6

Weingarten, , Germany

Countries

Germany

Other Identifiers

207

Identifier Type: -

Identifier Source: org_study_id