
1/14/2008 Telecon - Rotarix


 

 
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
