Product Approval Information
MEMORANDUM
| DATE: | January 14, 2008 |
| FROM: | Laraine S. Henchal, Microbiologist Reviewer, DVRPA, CBER, Review Committee Chair, STN 125265/0 |
| SUBJECT: | Telecon to discuss the post-market surveillance plan for STN #125265/0, Rotarix®, Rotavirus Vaccine, Live, Oral from GlaxoSmithKline Biologicals |
This meeting was held to discuss preliminary comments on the post-market study plan sent to GSK on December 18, 2007. In addition, the plan will be discussed at the VRBPAC next month.
We are requiring that GSK conduct a post-marketing study in the U.S. of sufficient size to determine a releative risk of intususception of 2.5 or greater. This would probably necessitate a study of at least 44,000 subjects. We would request that this study be conducted at sites outside of the VSD. Outcome measures will also need to include bronchitis and pneumonia related outcomes (including lower respiratory related hospitalizations), and Kawasaki's disease.
The status of the PASS study already underway in Mexico was discussed, with the possibility of adding some of the outcomes of interest to that study as well. GSK replied that they would attempt to do this, but were not sure what would be possible at those sites, but they thought that pneumonia could be added.
CBER participants:
Laraine Henchal
Jingyee Kou
Steve Rosenthal
Paul Kitsutani
Hector Izurieta
Luba Vujcic
GSK participants:
Leonard Friedland, Director, Clinical R&D Medical Affairs, Vaccines
Donna Boyce, Sr. Director, Vaccines, US Regulatory Affairs
Harry Seifert, Sr. Director and Head, North America Safety Evaluation & Risk Management
Camilo Acosta-Rodriguez, Director Epidemiology, Vaccines, North America
Remon Abu-Elyazeed, Director, Clinical R&D and Medical Affairs, Vaccines
Benedicte Dupasquier, Assoc. Director, Vaccines, US Regulatory Affairs
Gary Dubin, Vice President, North American Prophylactic Clinical R&D and Medical Affairs, Vaccines
Clare Kahn, Vice President, Vaccines, North American Regulatory Affairs
Elysia Tusavitz, Program Manager, Regulatory Affairs
Montse Soriano, Director, Worldwide Epidemiology, Vaccines
Rudi Scheerlinck, Director, Safety, Paediatric Vaccines
Tom Verstraeten, Head Worldwide Safety, Vaccines
Clare Kahn, Vice President, North America, Regulatory Affairs, Vaccines
Barbara Howe, Vice President, North American Prophylactic Clinical R&D, Medical and Regional Affairs, Vaccines