Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Record of Telephone Conversation, October 13, 2011 - MenHibrix

Submission Type: BLA    Submission ID: 125363/0    Office: OVRR

Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine

GlaxoSmithKline Biologicals

Telecon Date/Time: 13-Oct-2011 03:30 PM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
1. Advice


Telecon Summary:
Item 2.b.i Clarification Response


Non-FDA Participants: JODY GOULD

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

From: Prutzman, Kirk C

Sent: Thursday, October 13, 2011 3:25 PM

To: 'Jody Gould'

Cc: Temenak, Joseph; Staten, David

Subject: RE: BL/STN 125363 MenHibrix - Request for Clarification


We have received a response from our review team regarding clarification of Item 2.b.i.  Briefly, the reviewer is concerned about the impact of the –b(4)---------- on the variance of the samples that would be dependent on the titer of the sample.  This is essentially your "second suggestion" in your email below.  Let me know if this needs further clarification.

Regarding your submission of Item 26.  Sean Byrd has received the manual visual inspection data and is currently reviewing it.  There are no comments at this time. 

We have also received your intent to file amendment. 




From: Jody Gould []

Sent: Wednesday, September 28, 2011 11:43 AM

To: Prutzman, Kirk C

Subject: BL/STN 125363 MenHibrix - Request for Clarification

Importance: High

Dear Kirk,

I am writing to request clarification on one question in the September 21 CR letter.

Specifically, we would like clarification of the sentence in Item 2.b.i:  Please show that the –b(4)-------- algorithm is independent of sample titer, i.e., that the variance of the         --b(4)---------- ratio is constant relative to titer.

Could the reviewer please clarify if this refers to variation of the variance due to the titers of the controls, or to an impact of the ---b(4)------- factor on the variance of the samples that would be dependent on the samples’ titers.

Note that we may have additional items for clarification as we continue to review the letter and assess CBER’s requests in detail.

Also, in case you haven’t seen them yet:

-          Manual visual inspection information (response to request from S. Byrd) was submitted on September 23.

-          Intent to File Amendment was submitted on September 26.

Thank you!


Jody Ann Gould, PhD
Senior Director
US Regulatory Affairs
610-787-3765 (phone)
610-787-7063 (fax)

Trade secret and/or confidential commercial information contained in this message (including any attachments) is exempt from public disclosure to the full extent provided under law. If you are not the intended recipient of this message, or if you are not responsible for delivering it to the intended recipient(s), do not use, disclose, reproduce, or distribute this message (including any attachments). If you have received this message in error, please erase all copies (including any attachments) and notify me immediately.

Thank you.

Page Last Updated: 07/15/2012
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English