CMC Comments - June 29, 2009

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Date:  June 29, 2009

To:  Elisa Harkins, GSK

From:  Jason Humbert, CBER/OVRR/DVRPA

Through:  Jay Slater, M.D. Committee Chair

Subject:  CMC Comments related to Hiberix Package Insert
                  STN 125347/0

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I. Package Insert (draft.proposed.pdf)

Page 2, Line 15

Comment: You have provided data supporting storage of reconstituted vaccine for 24 hr at 2-8 degrees and at a --b(4)-- temperature.  We recommend that the label suggest that the reconstituted vaccine be stored for up to “24 hours at 2-8 degrees."

Comment: The current ongoing stability protocol only addresses reconstitution with the description test - upon reconstitution the sample shall be a clear, colorless solution. The 24-hour hold time after reconstitution needs to be addressed as part of your ongoing stability program (see 21 CFR 211.166).

Pages 6-7 DESCRIPTION section

The package insert should include information on both H. influenzae and tetanus cultures, and on the preparation of tetanus toxoid.

Page 9, Sections 16.1 and 16.2

The recommended storage conditions for the lyophilized vaccine and diluent are acceptable as stated for vaccine before reconstitution. However, after reconstitution it should read "at 2-8 degrees" instead of "between 4 and 30 degrees."

Line 149

Please include an Lf value for the tetanus toxoid in Hiberix. Thus, the sentence here should read “25 mcg or _____ Lf of inactivated tetanus toxoid".