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:
Novartis
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01562444
First received: March 13, 2012
Last updated: April 2, 2013
Last verified: April 2013
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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
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: | April 2, 2013 |
| Health Authority: | Czech Republic: State Institute for Drug Control (SUKL) |
Keywords provided by Novartis:
|
Long term immunogenicity study |
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 May 23, 2013