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Trial record 5 of 20 for:    pfizer | Tick-Borne Encephalitis
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Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 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: NCT00161863
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.

Condition or disease Intervention/treatment Phase
Tick-borne Encephalitis Biological: FSME-IMMUN NEW 0.25 ml Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Study Start Date : September 2002
Study Completion Date : January 2003

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

Male and female children and adolescents will be eligible for participation in this study if:

  • they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday);
  • they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial);
  • their parents/legal guardians understand the nature of the study and agree to its provisions;
  • written informed consent is available from both parents/legal guardians,
  • for Germany/Austria: additional written informed consent is available for children older than 8 years
  • they or their parents/legal guardians agree to keep a volunteer diary.

For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria:

- negative pregnancy test at study entry;

Exclusion Criteria:

Children and adolescents will be excluded from participation in this study if they:

  • have a history of any TBE vaccination;
  • have a history of TBE infection;
  • have a history of allergic reactions to one of the components of the vaccine;
  • 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;
  • are known to be HIV positive (a special HIV test is not required for the purpose of the study);
  • have received banked blood or immunoglobulins within one month of study entry;
  • have a history of vaccination against yellow fever and/or Japanese B-encephalitis;
  • suffer from hemorrhagic diathesis;
  • are participating simultaneously in another clinical trial;
  • if female: are pregnant or breastfeeding.

Volunteers who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature > 38°C) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.

Volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not be vaccinated until an interval of 4 weeks has passed. In this case visit 1 will take place separately.

If volunteers have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.

Volunteers who have a positive TBE antibody value prior to the first vaccination will be excluded from the statistical analysis of the primary endpoint.

Contacts and Locations
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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): NCT00161863


Locations
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Austria
Grieskirchner Strasse 17
Wels, Austria, 4600
Germany
Marktplatz 3
Bad Saulgau, Germany, 88348
Solothurner Strasse 2
Heilbronn, Germany, 74072
Hauptstraße 240
Kehl, Germany, 77694
Poland
Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny
Kielce, Poland, 25381
Szpital Jana Pawla II Odz. Neuroinfekcji
Krakow, Poland, 31202
Samodzielny Publiczny ZOZ Oddzial Dzieciecy
Lubartow, Poland, 21100
PANTAMED sp.z.o.o.
Olsztyn, Poland, 10-461
Sponsors and Collaborators
Pfizer
Investigators
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Principal Investigator: Baxter BioScience Investigator Baxter BioScience
More Information
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ClinicalTrials.gov Identifier: NCT00161863    
Other Study ID Numbers: 209
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