Product Approval Information - Licensing Action
September 5, 2008
Our Submission Tracking Number (STN): BL 125122/368
Merck & Co., Inc.
Attention: Paul L. Koser, Ph.D.
P.O. Box 1000
UG2D-68
North Wales , PA 19454-1099
Dear Dr. Koser:
We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, Pentavalent, to include pertussis immune response data from the Rotavirus Efficacy and Safety Trial (REST) to support concomitant use of DTaP with RotaTeq ®.
This fulfills your commitment as stated in commitment number 2 of the February 3, 2006, approval letter, "To conduct an adequately powered non-inferiority study of the concomitant administration of RotaTeq ® with acellular pertussis vaccine in which serological endpoints will be examined using a validated assay. The study will be powered sufficiently to detect a 1.5-fold difference in GMTs.” This commitment was discussed in a July 18, 2006 Type C meeting and later modified in IND ------ amendments dated June 26, 2007 and August 15, 2007, to accept data obtained from the re-testing of existing clinical REST trial samples using a validated assay in lieu of conducting a new clinical study in order to rule out interference with immune response when RotaTeq ® is concomitantly administered with an acellular pertussis vaccine.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
/s/
Wellington Sun, M.D.
Director
Division of Vaccines and
Related Products Applications
Office of Vaccines Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling