BioCentury's websites will be down for upgrades starting at 9 p.m. PDT on Monday, August 26. We expect the downtime to last no more than 6 hours, and we apologize for any inconvenience.

6:09 PM
Nov 12, 2012
 |  BC Extra  |  Company News

Reviewers: data support accelerated approval for adjuvanted flu vaccine

FDA reviewers said immunogenicity and safety data from two Phase III trials fulfill immunogenicity criteria to support accelerated approval of Q-Pan H5N1 adjuvanted vaccine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). In the Q-Pan-H5N1-001 and Q-Pan-H5N1-002 trials, the injectable adjuvanted influenza vaccine met the primary immunogenicity endpoints based on a surrogate marker -- vaccine induced hemagglutination-inhibition (HAI) -- that is "reasonably...

Read the full 287 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

$50 USD
More Info >