Preliminary safety data in adults and the elderly indicate that the vaccine is well tolerated in these age groups. The observed systemic and local reactions are similar to those generally experienced after vaccination with licensed seasonal influenza vaccines. Immunogenicity data from the first vaccination in adults are due later this month. The current dosing schedule, as specified in the EMEA mock-up licensure for CELVAPAN using another virus strain, calls for two 7.5 ?µg doses of vaccine to be given 21 days apart. Baxter expects the data from the trial of healthy adults to indicate whether a single dose may be possible for CELVAPAN H1N1. This study will also determine whether a lower dose, 3.75?µg, is sufficient to induce the necessary immune response.

"We are pleased that the regulatory submission and the preliminary clinical trial data uphold the extensive work done by Baxter and the support received from key Ministries of Health in developing a pandemic vaccine, said Hartmut J. Ehrlich, M.D., vice president of global research and development for Baxter BioScience. We are looking forward to analyzing the immunogenicity data for our cell culture-derived, non-adjuvanted vaccine to assess the potential of a one dose regimen.

Source Baxter International Inc