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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
207
Single 0.5 mL intramuscular dose
Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
Kokkola, Keski-Pohjanmaa, Finland
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
Oulu, North Ostrobothnia, Finland
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
Tampere, Pirkanmaa, Finland
Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™
Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge.
Time frame: Day 30
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
Participant serum samples will be assessed with an ECi assay for anti-HBs geometric mean concentrations (GMCs) pre-challenge on Day 1 and 30 days post-challenge with HBVAXPRO™ in mIU/mL.
Time frame: Day 1 and Day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Seinajoki Vaccine Research Center ( Site 0010)
Seinajoki, Pohjanmaa, Finland
Porin rokotetutkimusklinikka ( Site 0008)
Pori, Satakunta, Finland
Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
Turku, Southwest Finland, Finland
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
Espoo, Uusimaa, Finland
Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
Helsinki, Uusimaa, Finland
Ita-Helsingin Rokotetutkimuskeskus ( Site 0006)
Helsinki, Uusimaa, Finland
Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
Jarvenpaa, Uusimaa, Finland