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An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106482
First Posted: April 20, 2010
Last Update Posted: December 8, 2011
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.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
  Purpose
This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine

Condition Intervention Phase
Tick Borne Encephalitis (TBE) Other: Serology blood draw Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Open-label, Multi-center Follow-up Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Vaccines ):

Primary Outcome Measures:
  • Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination [ Time Frame: 3 years after vaccination ]
  • Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination [ Time Frame: 4 years after vaccination ]
  • Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination [ Time Frame: 5 years after vaccination ]

Secondary Outcome Measures:
  • Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination [ Time Frame: 3 years after vaccination ]
  • Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination [ Time Frame: 4 years after vaccination ]
  • Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination [ Time Frame: 5 years after vaccination ]

Enrollment: 126
Study Start Date: May 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Other: Serology blood draw
Blood draw only, no vaccine
Active Comparator: Arm 2 Other: Serology blood draw
Blood draw only, no vaccine
Active Comparator: Arm 3 Other: Serology blood draw
Blood draw only, no vaccine
Active Comparator: Arm 4 Other: Serology blood draw
Blood draw only, no vaccine

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian informed consent

Exclusion Criteria:

  • Subjects who did not receive complete schedule of primary vaccination in the parent study
  • Subjects enrolled in other investigational studies at the same time and within the last three months
  • Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
  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): NCT01106482


Locations
Germany
Winkelhoferstr. 3
Ehingen, Germany, 89584
Fuggerplatz 1
Kaufering, Germany, 86916
Hauptstrasse 240
Kehl, Germany, 77694
Bismarckstr. 3
Ludwigsburg, Germany, 71634
Am Marktplatz 8
Oberkirch, Germany, 77704
Großbottwarer Str. 47
Oberstenfeld, Germany, 71720
Wilhelmstr. 7
Offenburg, Germany, 77654
Stuttgarter Str. 74
Stuttgart, Germany, 70469
Martin-Niemöller-Str. 2
Traunreut, Germany, 83301
Murnauer Str. 3
Weilheim, Germany, 82362
Sponsors and Collaborators
Novartis Vaccines
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01106482     History of Changes
Other Study ID Numbers: M48P3E1
First Submitted: April 12, 2010
First Posted: April 20, 2010
Last Update Posted: December 8, 2011
Last Verified: December 2011

Keywords provided by Novartis ( Novartis Vaccines ):
TBE
Tick Borne Encephalitis

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs