Hepatitis B Vaccine \[Recombinant\] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: \[1\] induce protection against the morbidity and mortality of acute hepatitis B virus infection, \[2\] reduce the incidence of chronic infection in vaccinated populations, and \[3\] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine \[Recombinant\] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine \[Recombinant\] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
566
RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.
Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.
Geometric mean titer to hepatitis B surface antigen at Month 7
Time frame: 4 weeks Post Dose 3
Safety and tolerability including use of Vaccination Report Card
Time frame: Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.