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Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

Primary Purpose

Tick-borne Encephalitis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Tick-borne encephalitis vaccine
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tick-borne Encephalitis

Eligibility Criteria

6 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Neuschwansteinstrasse 5
  • Marktplatz 33
  • Hauptstrasse 9
  • Salzgasse 11
  • Mohrenstrasse 8
  • Bahnhofstrasse 1
  • Rheinstrasse 13
  • Peter-Seifert Strasse 5
  • Solothurner Strasse 2
  • Hauptstraße 240
  • Schwarzwaldstrasse 20
  • Altoettingerstrasse 3
  • Rastatter Strasse 7
  • Wilhelmstrasse 25
  • Heubischer Strasse 39
  • Dohmbuehlerstrasse 8
  • Schwarzwaldstrasse 18
  • Wilhelmstrasse 7
  • Asternweg 11a
  • Bergstrasse 27
  • Berneckstrasse 19
  • Hauptstrasse 11
  • Broner Platz 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
May 20, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00161798
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick-borne Encephalitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Tick-borne encephalitis vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Behre, MD
Organizational Affiliation
Hauptstrasse 240, 77694 Kehl, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuschwansteinstrasse 5
City
Augsburg
ZIP/Postal Code
86163
Country
Germany
Facility Name
Marktplatz 33
City
Bad Saulgau
ZIP/Postal Code
88348
Country
Germany
Facility Name
Hauptstrasse 9
City
Bietigheim-Bissingen
ZIP/Postal Code
74321
Country
Germany
Facility Name
Salzgasse 11
City
Calw
ZIP/Postal Code
75365
Country
Germany
Facility Name
Mohrenstrasse 8
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Bahnhofstrasse 1
City
Elzach
ZIP/Postal Code
79215
Country
Germany
Facility Name
Rheinstrasse 13
City
Ettenheim
ZIP/Postal Code
77955
Country
Germany
Facility Name
Peter-Seifert Strasse 5
City
Gersfeld
ZIP/Postal Code
36129
Country
Germany
Facility Name
Solothurner Strasse 2
City
Heilbronn
ZIP/Postal Code
74072
Country
Germany
Facility Name
Hauptstraße 240
City
Kehl
ZIP/Postal Code
77694
Country
Germany
Facility Name
Schwarzwaldstrasse 20
City
Kirchzarten
ZIP/Postal Code
79199
Country
Germany
Facility Name
Altoettingerstrasse 3
City
Landsberg
ZIP/Postal Code
86899
Country
Germany
Facility Name
Rastatter Strasse 7
City
Mannheim-Secken
ZIP/Postal Code
68239
Country
Germany
Facility Name
Wilhelmstrasse 25
City
Metzingen
ZIP/Postal Code
72555
Country
Germany
Facility Name
Heubischer Strasse 39
City
Neustadt/Cbg
ZIP/Postal Code
96465
Country
Germany
Facility Name
Dohmbuehlerstrasse 8
City
Nürnberg
ZIP/Postal Code
90449
Country
Germany
Facility Name
Schwarzwaldstrasse 18
City
Oberkirch
ZIP/Postal Code
77704
Country
Germany
Facility Name
Wilhelmstrasse 7
City
Offenburg
ZIP/Postal Code
77654
Country
Germany
Facility Name
Asternweg 11a
City
Offenburg
ZIP/Postal Code
77656
Country
Germany
Facility Name
Bergstrasse 27
City
Rottweil
ZIP/Postal Code
78628
Country
Germany
Facility Name
Berneckstrasse 19
City
Schrammberg
ZIP/Postal Code
78713
Country
Germany
Facility Name
Hauptstrasse 11
City
Tegernsee
ZIP/Postal Code
83681
Country
Germany
Facility Name
Broner Platz 6
City
Weingarten
ZIP/Postal Code
88250
Country
Germany

12. IPD Sharing Statement

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Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

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