Clinical trial NCT00161772: Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.
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 1 to 6 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tick-borne Encephalitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine in healthy children aged 1 to 6 years.


Eligibility criteria: Inclusion Criteria:

Male and female children will be eligible for participation in this study if:

* they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th birthday) old;
* they are clinically healthy;
* their legal representative understands the nature of the study, agrees to its provisions and gives written informed consent;
* their legal representative agrees to keep a Volunteer Diary.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Grieskirchner Strasse 17
city: Augsburg
country: Germany
facility: Neuschwansteinstrasse 5
city: Bad Saulgau
country: Germany
facility: Marktplatz 3
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 13
city: Gersfeld
country: Germany
facility: Peter-Seifert-Strasse 5
city: Heilbronn
country: Germany
facility: Solothurner Strasse 2
city: Kehl
country: Germany
facility: Hauptstraße 240
city: Kirchzarten
country: Germany
facility: Schwarzwaldstrasse 20
city: Landsberg
country: Germany
facility: Altoettingerstrasse 3
city: Mannheim-Secken
country: Germany
facility: Rastatter Strasse 7
city: Neustadt/Cbg
country: Germany
facility: Heubischer Strasse 39
city: Nürnberg
country: Germany
facility: Dohmbuehlerstrasse 8
city: Nürnberg
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: Schrammberg
country: Germany
facility: Berneckstrasse 19
city: Tegernsee
country: Germany
facility: Hauptstrasse 11
city: Weingarten
country: Germany
facility: Broner Platz 6
Study officials:
affiliation: Hauptstrasse 240, 77694 Kehl, Germany
name: Ulrich Behre, MD
role: PRINCIPAL_INVESTIGATOR
References: