CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 206 enrolled
Drug / intervention
Blood drawother
Likely dose
Not stated in record
Key inclusion· 1
  • ✓Completion of prior study V48P7E1
Key exclusion· 3
  • ✕Antibody responses to booster vaccine fell below protective levels
  • ✕Exposure to TBE or flavivirus vaccine
  • ✕Immunosuppression

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01562444
NCT01562444Phase 4Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Mar 23, 2012·Updated Aug 12, 2021

In Brief

A Phase 4 clinical trial evaluating Blood draw for Tick Borne Encephalitis and Virus Diseases. Completed, enrolled 206 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTick Borne Encephalitis, Virus Diseases
CountriesCzechia
CollaboratorsNovartis Vaccines

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2012
Enrollment StartMar 8, 2012
Primary CompletionSep 30, 2016
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 14.3 years ago

Interventions

Blood drawother

Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)