System Info - 118700 SMITH, MICHAEL J 27-Jan-2010 12:09:53 SMITHM
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 26-JAN-2010 05:54 PM Initiated by FDA? Yes
Author: JULIENNE VAILLANCOURT
Clinical PMC's sent to Wyeth for review and concurrence
FDA Participants: Julie Vaillancourt, Colleen Sweeney and Mike Smith
Non-FDA Participants: Jack Love and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Vaillancourt, Julienne
Sent: Tuesday, January 26, 2010 5:54 PM
To: 'Love Jack'; Devlin Carmel
Cc: Smith, Michael (CBER); Sweeney, Colleen
Subject: Clinical PMCs
Dear Jack and Carmel,
Attached is the set of written clinical post marketing commitments for inclusion in the approval letter. The dates in these PMCs were taken from the table you provided in your December 4, 2009 e-mail to me with a December 30, 2009 approval date in mind. Please let me know if you would like to propose revising any of these dates. You will see that this set is actually a subset of the PMCs provided in your December 4, 2009 table. We decided to not include submission of clinical study reports of the ongoing open label study in Alaska and the ongoing NP carriage study in Israel as commitments in the approval letter. However, we expect that you would be submitting these CSRs anyway. We look forward to your final agreement on the clinical PMCs for inclusion in the approval letter as written or with slight revisions to some dates based on delayed approval.
Julienne Vaillancourt, R.Ph., M.P.H.
Captain, US Public Health Service
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
US Food and Drug Administration
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Contents of attached MS Word file:
AGREED UPON POSTMARKETING COMMITMENTS
Postmarketing studies subject to reporting requirements of 21 CFR 601.70
We acknowledge your written commitments as described in your correspondence and submissions of March 31, June 11, July 22, August 7, October 1, October 21, December 2, December 9 and December 11, 2009, and January 14 and January 20, 2010, as outlined below:
- You agree to conduct study 6096A1-4002, a post-licensure observational study in a cohort of children at Northern California Kaiser Permanente who receive Prevnar 13 as part of routine medical care, to expand the understanding of the safety profile of Prevnar 13. At least 43,000 subjects in the total cohort will receive all three infant series doses. The final protocol for this study will be submitted by January 29, 2010. The study will begin in May 2010 and be completed by December 31, 2013. The final study report will be submitted by September 30, 2014.
- You agree to conduct study 6096A1-4005, an observational database study to monitor the impact of Prevnar 13 in preventing overall invasive pneumococcal disease in Northern California Kaiser Permanente members, by estimating the impact of Prevnar 13 routine use on the annual incidence rate of invasive pneumococcal disease during the five-year surveillance period in the study population. The final protocol for this study will be submitted by January 29, 2010. The study will begin in May 2010 and be completed by June 30, 2015. The final study report will be submitted by March 31, 2016.
- You agree to conduct study 6096A1-4010, a post-licensure observational study to evaluate the impact of Prevnar 13 routine use in reducing acute otitis media (AOM) and nasopharyngeal colonization in young children caused by the serotypes in the vaccine. S. pneumoniae isolates obtained from tympanocentesis, nasopharyngeal and oropharyngeal samples from subjects in this study will be serotyped. The final protocol for this study will be submitted by March 31, 2010. The study will be initiated by September 30, 2010, and be completed by September 30, 2015. The final study report will be submitted by March 31, 2016.
- You agree to conduct a study to monitor the impact of Prevnar 13 routine use in reducing AOM caused by serotypes in the vaccine via the United States Pediatric Multicenter Pneumococcal Surveillance Group (USPMPSG), a laboratory-based surveillance network of eight pediatric hospitals across the United States. In this study S. pneumoniae isolates from identified AOM cases will be serotyped. The final protocol for this study will be submitted by March 31, 2010. The study will be initiated by December 31, 2010, and completed by December 31, 2013. The final study report will be submitted by September 30, 2014.
- You agree to conduct study 6096A1-4018, an ecologic study to assess national trends in health care visits for otitis media in children younger than five years of age. This study will utilize ambulatory health care visit data from annual national surveys conducted by the National Center for Health Statistics. The final protocol for this study will be submitted by March 31, 2010. The study will be initiated by December 31, 2010, and be completed by December 31, 2013. The final study report will be submitted by September 30, 2014.
End of email.