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FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years

Last updated on November 17, 2019

FOR MORE INFORMATION
Study Location
Grieskirchner Strasse 17
Wels, , A-4600 Austria
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
1-6 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

All volunteers who participated in Baxter study 199 and received two vaccinations will be
invited to participate. Male and female children will be eligible for participation in
this study if:

- They received two vaccinations with one of the three different dosages of FSME IMMUN
NEW during the course of Baxter study 199

- Written informed consent from the legal guardian is available.

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

There are no specific exclusion criteria for this study entry. However volunteers will be
assessed for eligibility to receive a third vaccination.

Volunteers will be excluded from vaccination and consecutive visits in this study if they:

- Are not clinically healthy, (i. e. the physician would have reservations vaccinating
with FSME IMMUN NEW outside the scope of a clinical trial)

- Have already been administered a third TBE vaccination elsewhere after the two
vaccinations in Baxter study 199

- Have had an allergic reaction to one of the components of the vaccine since the last
vaccination in Baxter study 199

- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment
(e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence
immunological functions

- Have received banked human blood or immunoglobulins within one month of study entry

- Are known to be HIV positive (a special HIV test is not required for the purpose of
the study) since the last visit of Baxter study 199

- Have had a vaccination against yellow fever and / or Japanese B-encephalitis since
the last visit in Baxter study 199

- Had received an investigational new drug within 6 weeks prior to study start

NCT00161850
Pfizer
Completed
FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years

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Descriptive Information
Brief Title  ICMJE FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years
Official Title  ICMJE Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 1 to 6 Years
Brief SummaryThe purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Condition  ICMJE Encephalitis, Tick-borne
Intervention  ICMJE Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
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
 (submitted: September 12, 2005)
615
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2002
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

All volunteers who participated in Baxter study 199 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:

  • They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 199
  • Written informed consent from the legal guardian is available.

Exclusion Criteria:

There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.

Volunteers will be excluded from vaccination and consecutive visits in this study if they:

  • Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)
  • Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 199
  • Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199
  • Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
  • Have received banked human blood or immunoglobulins within one month of study entry
  • Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 199
  • Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199
  • Had received an investigational new drug within 6 weeks prior to study start
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Year to 6 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 NCT00161850
Other Study ID Numbers  ICMJE 206
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:Baxter BioScience InvestigatorBaxter Healthcare Corporation
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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