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Trial record 6 of 20 for:    pfizer | Tick-Borne Encephalitis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161798
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Tick-borne Encephalitis Biological: Tick-borne encephalitis vaccine Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : September 2001
Study Completion Date : March 2002

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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161798


Locations
Show Show 23 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Principal Investigator: Ulrich Behre, MD Hauptstrasse 240, 77694 Kehl, Germany
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ClinicalTrials.gov Identifier: NCT00161798    
Other Study ID Numbers: 205
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Encephalitis, Tick-Borne
Encephalitis
Encephalitis, Arbovirus
Encephalitis, Viral
Infectious Encephalitis
Tick-Borne Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Viral Diseases
Central Nervous System Infections
Infections
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections