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Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules

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ClinicalTrials.gov Identifier: NCT01562444
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The aim of this study is to investigate the immunogenicity response in adults up to 10 years after one booster dose. Data collected from this study will allow for greater information to prescribers who administer TBE vaccine, so that they can appropriately time the administration of booster vaccinations to individuals who received different vaccination schedules and who live in tick borne encephalitis endemic regions.

Condition or disease Intervention/treatment Phase
Tick Borne Encephalitis Other: Blood Sampling Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase IV, Open-label, Single-center Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules
Study Start Date : March 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Arm Intervention/treatment
Group 1
Blood sampling
Other: Blood Sampling
Annual blood draws



Primary Outcome Measures :
  1. Antibody responses in subjects for up to 10 years following booster vaccination. [ Time Frame: 6 to 10 years after first booster with TBE vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who have completed prior study - V48P7E1.

Exclusion Criteria:

  • Subjects whose antibody responses to booster vaccine received in the parent study fell below protective levels, subjects who have been exposed to TBE or flavivirus vaccine, subjects with immunosuppression.

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): NCT01562444


Locations
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 50002
Sponsors and Collaborators
GlaxoSmithKline
Novartis Vaccines
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01562444     History of Changes
Other Study ID Numbers: 205335
2011-003255-19 ( EudraCT Number )
V48P7E2 ( Other Identifier: Novartis )
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by GlaxoSmithKline:
Long term immunogenicity study

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs