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Company successfully completes StaphVAX immunogenicity study.
2003 OCT 8 - (NewsRx.com & NewsRx.net) -- Nabi Biopharmaceuticals (NABI) announced the successful completion of an immunogenicity trial using material from the lot of StaphVAX (Staphylococcus aureus Polysaccharide Conjugate Vaccine) intended for use in a confirmatory phase III trial later this year.
The immunogenicity trial was an open-label, single-dose study in 40 healthy volunteers that evaluated the antibody response to StaphVAX.
"The results from this trial are an important proof that we can successfully transfer production of StaphVAX to a contract manufacturing facility. This study demonstrated that this lot of vaccine generates antibody levels that are at least as good as those generated from vaccine manufactured in our R&D pilot plant and used in our previous phase III clinical trial," said Henrik S. Rasmussen, MD, PhD, senior vice president, clinical, medical, and regulatory affairs.
He continued, "In addition, the results from this immunogenicity trial continued to demonstrate an excellent safety and tolerability profile for StaphVAX. While completing this study, we ...
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