|From:||Tiernan, Rose (CBER)|
|Sent:||Tuesday, June 05, 2007 5:33 PM|
|Cc:||Rosenthal, Steve; Kitsutani, Paul; Izurieta, Hector; Kou, Jingyee; Henchal, Laraine|
As per our phone conversation.thanks and....we did receive the Rotarix BLA!
We already discussed adding Kawasaki disease to the post-marketing PASS study.
We now also request that GSK provide a summary of Kawasaki disease (KD) reports from both your clinical trial experience and also from your post-marketing experience.
Regarding your clinical trial experience, we think that the best way to approach this would be to summarize the KD cases per individiual clinical study because the studies were done in different countries, using different doses and schedules.
We are intereresed in all of your clinical trial experience. For each study, could you please summarize the number of infants in the vaccine and placebo arm per study, dosing schedule used, dose used, country where study conducted, capture KD cases in relation to vaccine dose (dose # 1or #2) and time post vaccine dose when KD occurred. We need to know what terms you will use to assess KD cases e.g. whether your analysis just used the term "Kawaski Disease" to search or whether you used other terms or groups of terms (fever, conjunctivitis, lymphadenopathy, etc). Please include infant age at first vaccine dose and at time of "Kawasaki" diagnosis and concomitant vaccinations administered.
Can you also summarize the number of KD cases that occurred in the vaccine vs the placebo arm for the entire clinical trial database.
Many Thanks, Judy, and we can touch base further if questions arise and also need to have an idea regarding the time when your staff would be able to provide this information/analysis.
In addition, when in Brazil at the WHO meeting on May 23, 2007 Tom Verstraeten had some questions regarding "expedited reporting" of intussusception cases to CBER and I spoke with Hector who said he would be glad to telecon with Tom if he has questions.
Thanks and I have cc'ed others who will be working on Rotarix.