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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01562444
First received: March 13, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Tick Borne Encephalitis
Other: Blood Sampling
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Antibody responses in subjects for up to 10 years following booster vaccination. [ Time Frame: 6 to 10 years after first booster with TBE vaccination ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: March 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
Blood sampling
Other: Blood Sampling
Annual blood draws

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT01562444

Locations
Czech Republic
Vaccination and Travel Medicine Center, Poliklinika II
Bratri Stefanu 895, Hradec Kralove, Czech Republic, 500 03
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01562444     History of Changes
Other Study ID Numbers: V48P7E2, 2011-003255-19
Study First Received: March 13, 2012
Last Updated: June 23, 2014
Health Authority: Czech Republic: State Institute for Drug Control (SUKL)

Keywords provided by Novartis:
Long term immunogenicity study

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
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 October 16, 2014