Nobilon advances intranasal seasonal influenza vaccine into proof of concept study

16-Oct-2009 - Netherlands

Nobilon, the human vaccine business unit of Schering-Plough Corporation, announced that it has initiated a clinical Proof of Concept trial with SCH 900795, a new intranasal Live Attenuated Influenza Vaccine (LAIV) for annual seasonal use.

“We are encouraged by the continuation of the clinical development program of SCH 900795 after interim results of Nobilon’s first ever Phase I study had demonstrated that the primary study end point was met,“ said Han van den Bosch, director R&D at Nobilon. “We remain on track to continue the development program of our LAIV for annual seasonal influenza vaccination. In the new study, we will investigate safety, tolerability and immunogenicity of SCH 900795 in 140 healthy adults of 50 years and older. We are pleased that the first subject in this double-blind, randomized, placebo-controlled study has been successfully dosed.”

The earlier Phase I study had a randomized, double-blind, placebo-controlled, rising single-dose design and included a total of 117 healthy volunteers between the ages of 19 and 50 years. The objectives of this study were to investigate the safety, tolerability and immunogenicity of escalating doses of SCH 900795.

LAIV differs from most existing influenza vaccines, because it has been designed to offer (1) single-dose intranasal delivery, (2) advanced cell culture manufacturing technology and (3) potential earlier and broader protection against infection by influenza viruses.

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