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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00387634
First received: October 11, 2006
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster


Condition Intervention Phase
Tick Born Encephalitis
Biological: TBE vaccine for adults
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 323
Study Start Date: September 2006
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   15 Years to 68 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00387634     History of Changes
Other Study ID Numbers: V48P7E1
Study First Received: October 11, 2006
Last Updated: November 1, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Novartis:
tick born encephalitis, TBE, adults

Additional relevant MeSH terms:
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections

ClinicalTrials.gov processed this record on April 23, 2014