Clinical trial NCT00161798: Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 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 6 to 16 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): 6
Maximum age (years): 15
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 will be investigated in healthy children aged 6 to 16 years.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Neuschwansteinstrasse 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 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: Metzingen
country: Germany
facility: Wilhelmstrasse 25
city: Neustadt/Cbg
country: Germany
facility: Heubischer Strasse 39
city: Nürnberg
country: Germany
facility: Dohmbuehlerstrasse 8
city: Oberkirch
country: Germany
facility: Schwarzwaldstrasse 18
city: Offenburg
country: Germany
facility: Wilhelmstrasse 7
city: Offenburg
country: Germany
facility: Asternweg 11a
city: Rottweil
country: Germany
facility: Bergstrasse 27
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: