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Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults

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: NCT00387634
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : November 2, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster

Condition or disease Intervention/treatment Phase
Tick Born Encephalitis Biological: TBE vaccine for adults Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase IV, Uncontrolled, Open-label, Single-center Study in Adolescents and Adults: Evaluation of Immunogenicity and Safety of the First Booster Immunization With Novartis' TBE Vaccine for Adults in Participants of Study V48P7 and Long-term Evaluation of Immunogenicity up to 5 Years After First Booster Immunization
Study Start Date : September 2006
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Arm 1
Blood draw only, no vaccine
Biological: TBE vaccine for adults
Serology blood draw.
Active Comparator: Arm 2
Blood draw only, no vaccine
Biological: TBE vaccine for adults
Serology blood draw.
Active Comparator: Arm 3
Blood draw only, no vaccine
Biological: TBE vaccine for adults
Serology blood draw.
Active Comparator: Arm 4
Blood draw only, no vaccine
Biological: TBE vaccine for adults
Serology blood draw.


Outcome Measures

Primary Outcome Measures :
  1. immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA [ Time Frame: On day 21, year 1, year 2, year 3, year 4, year 5 ]

Secondary Outcome Measures :
  1. safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting [ Time Frame: Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 68 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects who have completed study V48P7

Exclusion Criteria:

  • acute illness at day of immunization
  • general decrease in resistance
  • progressive neurological disorders
  • history of febrile or afebrile convulsions
  • major congenital defects
  • serious chronic illness
  • hypersensitivity to study vaccine
  • treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates
Contacts and Locations

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): NCT00387634


Locations
Czech Republic
Hradec Kralove, Czech Republic, 500 03
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines - Information Services Novartis
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00387634     History of Changes
Other Study ID Numbers: V48P7E1
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: November 2012

Keywords provided by Novartis ( Novartis Vaccines ):
tick born encephalitis, TBE, adults

Additional relevant MeSH terms:
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs