Human vaccines
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Randomized Controlled Trial Comparative Study
Safety, tolerability and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young adults.
Merck has developed a manufacturing process modification for RECOMBIVAX HB. Three lots of modified process hepatitis B vaccine (mpHBV) were studied in a randomized, blinded trial to demonstrate similarity of the three lots of mpHBV and noninferiority to RECOMBIVAX HB (control vaccine) with regard to immunogenicity. ⋯ The SPRs for the mpHBV groups and the control group were high; responses were consistent across the mpHBV groups. The mpHBV and control vaccines were generally well tolerated.