At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 207 enrolled
Drug / intervention
HBVAXPRO™biological
Likely dose
HBVAXPRO™ 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-Dose Infant Series and Toddler Dose of Vaxelis®
In Brief
A Phase 3 clinical trial evaluating HBVAXPRO™ for Hepatitis B. Completed, enrolled 207 participants across 10 sites.
Detailed Summary
The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing was performed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesFinland
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartSep 2020
Primary CompletionDec 2020
TodayJul 2026
First PostedJul 29, 2020
Enrollment StartSep 2, 2020
Primary CompletionDec 29, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.9 years ago
Interventions
HBVAXPRO™biological
Single 0.5 mL intramuscular dose