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

Tick-borne Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161798
• Other study ID #: 205
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: May 20, 2015
• Start date: September 2001
• Est. completion date: March 2002

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne
• Tick-borne Encephalitis

Intervention

Biological:
• Tick-borne encephalitis vaccine

Locations

Country	Name	City	State
Germany	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	Nürnberg
Germany	Schwarzwaldstrasse 18	Oberkirch
Germany	Asternweg 11a	Offenburg
Germany	Wilhelmstrasse 7	Offenburg
Germany	Bergstrasse 27	Rottweil
Germany	Berneckstrasse 19	Schrammberg
Germany	Hauptstrasse 11	Tegernsee
Germany	Broner Platz 6	Weingarten

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany,