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

Encephalitis, Tick-borne Clinical Trial

Official title:

Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 6 to 16 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161889
• Other study ID #: 207
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: May 20, 2015
• Start date: February 2002
• Est. completion date: August 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: August 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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:

There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.

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

Study Design

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

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne

Intervention

Biological:
• Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Locations

Country	Name	City	State
Germany	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	Nuernberg
Germany	Wilhelmstrasse 7	Offenburg
Germany	Berneckstrasse 19	Schramberg
Germany	Hauptstrasse 11	Tegernsee
Germany	Broner Platz 6	Weingarten

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany,