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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 28, 2014