A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
860
Number of Participants with Seroprotection to Hepatitis B Surface Antigen
Time frame: 1 month after the third vaccination (Month 7)
Geometric Mean Titers to Hepatitis B Surface Antigen
Time frame: 1 month after the third vaccination (Month 7)
Percentage of Participants with an Adverse Experience
Time frame: Up to 15 days after any vaccination
Percentage of Participants with an Injection-site Adverse Experience
Time frame: Up to 15 days after any vaccination
Percentage of Participants with a Systemic Adverse Experience
Time frame: Up to 15 days after any vaccination
Percentage of Participants with Fever (>=37.8°C, 100.0°F)
Time frame: Up to 5 days after any vaccination
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