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Vaccines, Blood & Biologics

Record of Telephone Conversation - Cervarix, July 26, 2009

System Info - 100607  SHONE, DEANNA   27-Jul-2009 17:48:50  SHONEDE



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


Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant


GlaxoSmithKline Biologicals          

Telecon Date/Time:  26-JUL-2009 02:22 PM     Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request


Telecon Summary:

Information Request RE: HPV-008

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

From: Gemignani, Helen S
Sent: Sunday, July 26, 2009 2:22 PM
To: ''
Cc: ''; 'Cynthia.A.D''
Subject: Cervarix BLA - Information Request RE: HPV-008

As noted in Table 97, p. 355 of the clinical study report for HPV-008, you provided summary results for prevention of 6-month and 12-month persistent infection with non-vaccine HPV types in the ATP cohort for efficacy and the TVC-1 cohort for efficacy. CBER requests that you provide these analyses for the TVC cohort as well. CBER understands that because the TVC cohort includes subjects who were PCR positive for the relevant non-vaccine HPV types at baseline, it is not possible to indicate the exact time of persistent infection in those who were PCR positive at baseline, because we do not know how long they were PCR positive prior to Day 1 of the study. Nonetheless,

1) CBER requests that you provide the following results for the TVC cohort, counting time of persistent infection from Day 1 for those who were PCR positive at baseline.

2) CBER also requests that you include these analyses for HPV 39, 52, 56, 59 and 66 as well.

Persistent infection and relationship to development to high-grade cervical dysplasia Summary table of vaccine efficacy against virological endpoints associated with specific oncogenic HPV types (by PCR) in HPV DNA negative subjects using conditional exact method

<< OLE Object: Picture (Metafile) >>

n=number of subjects reporting at least one event in each group (HPV group/HAV group).

Note: Only oncogenic HPV types with at least one statistically significant result are shown. Those results shown in bold were statistically significant.

Subjects with an event were HPV DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type in the ATP cohort for efficacy, and DNA negative and seronegative at Month 0 in TVC-1, VE (%) = Vaccine Efficacy (Conditional Method) LL, UL = 96.1% Lower and Upper confidence limits, P-value = Two-sided Fisher Exact test

Source: STN 125259.0048. CSR 008, Table 97, p. 355


Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Viral Vaccine Branch
(301) 827-3070


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