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Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

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ClinicalTrials.gov Identifier: NCT00161772
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date May 21, 2015
Study Start Date  ICMJE March 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Tick-borne Encephalitis
Intervention  ICMJE Biological: Tick-borne Encephalitis Vaccine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE August 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161772
Other Study ID Numbers  ICMJE 199
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulrich Behre, MD Hauptstrasse 240, 77694 Kehl, Germany
PRS Account Pfizer
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP