Clinical trial NCT00161889: FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Encephalitis, Tick-borne
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 615
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).


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:

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Neuschwanstein Strasse 5
city: Bad Saulgau
country: Germany
facility: Marktplatz 33
city: Bietigheim-Bissingen
country: Germany
facility: Hauptstrasse 9
city: Calw
country: Germany
facility: Salzgasse 11
city: Coburg
country: Germany
facility: Mohrenstrasse 8
city: Elzach
country: Germany
facility: Bahnhofstrasse 1
city: Ettenheim
country: Germany
facility: Rheinstrasse 1a
city: Gersfeld
country: Germany
facility: Peter-Seifert Strasse 5
city: Heilbronn
country: Germany
facility: Solothumer Strasse 2
city: Kehl
country: Germany
facility: Hauptstrasse 240
city: Kirchzarten
country: Germany
facility: Schwarzwald Strasse 20
city: Landsberg
country: Germany
facility: Altoettinger Strasse 3
city: Mannheim-Secken
country: Germany
facility: Rastatter Strasse 7
city: Metzingen
country: Germany
facility: Wilhelmstrasse 25
city: Nuernberg
country: Germany
facility: Dohmbuehler Strasse 8
city: Offenburg
country: Germany
facility: Wilhelmstrasse 7
city: Schramberg
country: Germany
facility: Berneckstrasse 19
city: Tegernsee
country: Germany
facility: Hauptstrasse 11
city: Weingarten
country: Germany
facility: Broner Platz 6
Study officials:
affiliation: Baxter Healthcare Corporation
name: Baxter BioScience Investigator
role: PRINCIPAL_INVESTIGATOR
References: