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mpHBV-Hib is an investigational combination vaccine developed by Merck Sharp & Dohme (MSD) for the prevention of invasive disease caused by *Haemophilus influenzae* type b (Hib) and infection caused by the hepatitis B virus (HBV) in infants. The vaccine is a biologic containing 5 μg of hepatitis B surface antigen (HBsAg) and 7.5 μg of Hib capsular polysaccharide conjugated to the Neisseria meningitidis outer membrane protein complex (PRP-OMPC). The "modified process" refers to a manufacturing change in the HBsAg component that incorporates double the standard amount of phosphate to enhance immunogenicity. In Phase 3 clinical trials, the vaccine was evaluated in a three-dose regimen (administered at 2, 4, and 12 months of age) and demonstrated safety and immunogenicity profiles comparable to the licensed combination vaccine COMVAX, achieving 100% seroprotection rates for hepatitis B.
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