VBI Vaccines (NASDAQ:VBIV) announces positive results from a second Phase 3 clinical trial, CONSTANT, evaluating lot-to-lot consistency of its Sci-B-Vac hepatitis B vaccine and comparing its safety and immunogenicity to GlaxoSmithKline’s (NYSE:GSK) Engerix-B.
The study met the primary endpoint of lot-to-lot consistency for immune response across three independent consecutively manufactured lots four weeks after the third vaccination.
Sci-B-Vac demonstrated non-inferior immunogenicity to Engerix-B at day 196, one month after the completion of the full course of vaccination with either product.
No new safety signals were observed.
Marketing application submissions in the U.S., Europe and Canada will begin in H2.
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