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:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01106482
First received: April 12, 2010
Last updated: December 7, 2011
Last verified: December 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Primary Outcome Measures:
  • Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination [ Time Frame: 3 years after vaccination ] [ Designated as safety issue: No ]
  • Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination [ Time Frame: 4 years after vaccination ] [ Designated as safety issue: No ]
  • Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination [ Time Frame: 5 years after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination [ Time Frame: 3 years after vaccination ] [ Designated as safety issue: No ]
  • Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination [ Time Frame: 4 years after vaccination ] [ Designated as safety issue: No ]
  • Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination [ Time Frame: 5 years after vaccination ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01106482     History of Changes
Other Study ID Numbers: M48P3E1
Study First Received: April 12, 2010
Last Updated: December 7, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
TBE
Tick Borne Encephalitis

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 15, 2014