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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.

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
Neuschwansteinstrasse 5
Augsburg, , 86163 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-borne Encephalitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-15 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00161798
Pfizer
Completed
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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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 6 to 16 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 6 to 16 Years.
Brief SummaryThe 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.
Detailed DescriptionNot 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 March 2002
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161798
Other Study ID Numbers  ICMJE 205
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Ulrich Behre, MDHauptstrasse 240, 77694 Kehl, Germany
PRS AccountPfizer
Verification DateMay 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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