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Vaccines

Record of Telephone Conversation - Cervarix, October 24, 2008

System Info - 94739  SHONE, DEANNA   20-May-2009 17:28:49  SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  24-OCT-2008 12:00 AM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Advice

Author:  HELEN GEMIGNANI

Telecon Summary:

CBER Statistical comments in response to GSK's 29-Sep-2008 HPV-008 RAP submission to the BLA.

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

 From:                     Gemignani, Helen S 

Sent:                      Friday, October 24, 2008 1:34 PM

To:                          'Matt.Whitman@gsk.com'

Cc:                          'Cynthia.A.D'Ambrosio@gsk.com'

Subject:                Comments on 9/29/08 BLA Submission

Following are some statistical comments RE: September 29, 2008, HPV-008 RAP submission to the BLA. Please let me know if you have any questions or need additional clarification.

1) There are more than 30 exploratory objectives to be evaluated in the Reporting and Analysis Plan for efficacy for HPV-008. In these analyses, Type I errors are not adjusted for multiple comparisons. Please acknowledge that results based on these analyses cannot be used to support post-licensure supplements for labeling changes.

2) Please refer to page 38, section 4.5.3. Given that the number of breakthrough cases will not be large, too many covariates presented in the Cox regression models may cause over-adjustment. In addition, collinearity between covariates may emerge. Please comment.

3) Please note some minor editing changes to be made on page 13: Please add “HRW (=High-risk (oncogenic) HPV types without HPV-16 or HPV-18: HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)” in the fourth paragraph

Helen Sullivan Gemignani

Regulatory Project Manager

Division of Vaccines and Related Products Applications

Office of Vaccines Research and Review

Center for Biologics Evaluation and Research

Food and Drug Administration

phone: (301) 827-3070

helen.gemignani@fda.hhs.gov

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