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Vaccines

Record of Email Receipt, September 16, 2011 - MenHibrix

 

BLA:               125363/12

Product:          MenHibrix

Sponsor:          GSK

Date/Time:      09-16-2011

From:              David C. Staten, Jr., MPH

FDA Participants:                  N/A

Non-FDA Participates:           N/A

Subject:

Received the following email from sponsor;

Clinical Items:
• We have discovered a minor error in the Summary of Clinical Efficacy in the BLA. As a result of a cut‐and‐paste error, in Appendix Table 4 of m 2.7.3 the anti‐PSY values for study Hib‐ MenCY‐TT‐006 are incorrect. All other data in the table (studies 008 and 010) are correct. Note that the data are not from a primary analysis and that the correct 006 data can be found in the Clinical Study Report (CSR) for ‐006 (Table 26) in m5.3.5.1 of the BLA. At this point, I propose not to update the Summary, since the correct data are available in the CSR.


ACTION: Discussed this issue with the MO. This error will not effect the clinical review or the outcome of the decision to issue an additional CR