Clinical trial NCT00161850: FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 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 1 to 6 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): 1
Maximum age (years): 6
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 subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).


Eligibility criteria: Inclusion Criteria:

All volunteers who participated in Baxter study 199 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 199
* Written informed consent from the legal guardian is available.

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 199
* Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199
* 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 199
* Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199
* Had received an investigational new drug within 6 weeks prior to study start

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Grieskirchner Strasse 17
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: Friedrichshafen
country: Germany
facility: Ehlerstrasse 17
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: Nuernberg
country: Germany
facility: Glogauer Strasse 15
city: Oberndorf/Neckar
country: Germany
facility: Tuchbergstrasse 2
city: Offenburg
country: Germany
facility: Wilhelmstrasse 7
city: Offenburg
country: Germany
facility: Asternweg 11a
city: Rottweil
country: Germany
facility: Bergstrasse 27
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: