study observed a higher rate of seroprotection in subject vaccinated with Fluzone HighDose than in those who received Fluzone. Safety Studies providing safety data Safety data is available from Studies FIM01, FIM05, FIM07, FIM12 submitted in this dossier as complete reports. Study NIH-01-574 was included in the dossier as a literature reference and so analysis of safety endpoints in this study was not possible. However, this dose ranging study included only a low number of subjects who received the proposed dose of Fluzone High-Dose. No study assessed a safety as a primary endpoint. Table 6 provides a summary of the safety endpoints collected in Studies FIM01, FIM07, FIM05 and FIM12. Table 6: Safety endpoints from Studies FIM01, FIM07, FIM05 and FIM12 Patient exposure Table 7 summaries the patient exposure to Fluzone and Fluzone High-Dose in the submitted studies. Table 7: Patient exposure in studies submitted in support of this submission to the TGA Study ID Fluzone visit of Last contact with High-Dose first subject last subject 2588 1288 9 October 9 July 2007 2006 FIM12 (Year 7254 7243 6 September 31 May 2013 1) 2011 FIM12 (Year 8738 8748 2) FIM01 206 208 11 April 2005 28 November 2005 6018 3050 22 September 28 May 2010 2009 NIH-01-597 50 at 18 June 2002 April 2003 proposed dose/202 at all doses Postmarketing data The sponsor has not provided Post Market Safety Update Reports (PSURs) or postmarketing data. They have noted that between February 2009 and February 2014 a total of 20,702,980 doses of Fluzone High-Dose were distributed in the US. The sponsor has referenced the US Product Information (Package Insert) regarding adverse events
study observed a higher rate of seroprotection in subject vaccinated with Fluzone HighDose than in those who received Fluzone. Safety Studies providing safety data Safety data is available from Studies FIM01, FIM05, FIM07, FIM12 submitted in this dossier as complete reports. Study NIH-01-574 was included in the dossier as a literature reference and so analysis of safety endpoints in this study was not possible. However, this dose ranging study included only a low number of subjects who received the proposed dose of Fluzone High-Dose. No study assessed a safety as a primary endpoint. Table 6 provides a summary of the safety endpoints collected in Studies FIM01, FIM07, FIM05 and FIM12. Table 6: Safety endpoints from Studies FIM01, FIM07, FIM05 and FIM12 Patient exposure Table 7 summaries the patient exposure to Fluzone and Fluzone High-Dose in the submitted studies. Table 7: Patient exposure in studies submitted in support of this submission to the TGA Study ID Fluzone High-Dose visit of first subject Last contact with last subject 2588 1288 9 October 2006 9 July 2007 FIM12 (Year 1) 7254 7243 6 September 2011 31 May 2013 FIM12 (Year 2) 8738 8748 FIM01 206 208 11 April 2005 28 November 2005 6018 3050 22 September 2009 28 May 2010 NIH-01-597 50 at proposed dose/202 at all doses 18 June 2002 April 2003 Postmarketing data The sponsor has not provided Post Market Safety Update Reports (PSURs) or postmarketing data. They have noted that between February 2009 and February 2014 a total of 20,702,980 doses of Fluzone High-Dose were distributed in the US. The sponsor has referenced the US Product Information (Package Insert) regarding adverse events