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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00161798
Other study ID # 205
Secondary ID
Status Completed
Phase Phase 2
First received September 8, 2005
Last updated May 20, 2015
Start date September 2001
Est. completion date March 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 three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date March 2002
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 15 Years
Eligibility 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.

Study Design

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


Intervention

Biological:
Tick-borne encephalitis vaccine


Locations

Country Name City State
Germany Neuschwansteinstrasse 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 13 Ettenheim
Germany Peter-Seifert Strasse 5 Gersfeld
Germany Solothurner Strasse 2 Heilbronn
Germany Hauptstraße 240 Kehl
Germany Schwarzwaldstrasse 20 Kirchzarten
Germany Altoettingerstrasse 3 Landsberg
Germany Rastatter Strasse 7 Mannheim-Secken
Germany Wilhelmstrasse 25 Metzingen
Germany Heubischer Strasse 39 Neustadt/Cbg
Germany Dohmbuehlerstrasse 8 Nürnberg
Germany Schwarzwaldstrasse 18 Oberkirch
Germany Asternweg 11a Offenburg
Germany Wilhelmstrasse 7 Offenburg
Germany Bergstrasse 27 Rottweil
Germany Berneckstrasse 19 Schrammberg
Germany Hauptstrasse 11 Tegernsee
Germany Broner Platz 6 Weingarten

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

See also
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Completed NCT00804219 - Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination Phase 4