Record of Telephone Conversation, May 29, 2012 - MenHibrix

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

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

Applicant:
GlaxoSmithKline Biologicals
 

Telecon Date/Time: 29-May-2012 11:24 AM        Initiated by FDA? Yes
 

Telephone Number:
 

Communication Categorie(s):
1. Other -

Author: KIRK PRUTZMAN
 

Telecon Summary:
Clincal and CMC PMCs sent to GSK for concurrance
 

FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN
 

Non-FDA Participants: JODY GOULD, NORRIS PYLE
 

Trans-BLA Group: No

 

Related STNs: None
 

Related PMCs: None
 

Telecon Body:

From:                     Prutzman, Kirk C
Sent:                      Tuesday, May 29, 2012 11:24 AM
To:                         Jody Gould; 'Norris Pyle'
Cc:                         Temenak, Joseph; Staten, David
Subject:                 STN 125363 - PMCs

Attachments:          STN 125363 PMCs.doc
Hi Jody and Norris,

Here is the list of PMCs (see attached) that will be included in the MenHibrix Approval Letter upon your concurrence.  Regarding ----b(4)--------------------------, please provide us with a submission date.  Please send an email that you agree to the PMCs and will commit to them. 
Regards,

Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
CBER/OVRR/DVRPA/CMC3
1451 Rockville Pike (WOC2)
Room 2241
HFM-481
Rockville, MD  20857
Phone:  (301) 796-2640

Clinical PMC:

1. To conduct a Phase IIIb open-label administration (laboratory personnel will be blinded to treatment), parallel-group, controlled, multicenter study to evaluate concomitant administration of MenHibrix with rotavirus, 13-valent pneumococcal conjugate and hepatitis A vaccines administered according to a US recommended vaccine schedule. 

The study is entitled “Phase IIIb open-label administration (laboratory personnel will be blinded to treatment), parallel-group, controlled, multicenter study to evaluate the immunogenicity, safety and reactogenicity of MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) when administered concomitantly with Rotarix (GlaxoSmithKline Biologicals’), Pediarix (GlaxoSmithKline Biologicals’) and Prevnar 13 (Pfizer) as compared to Pentacel (Sanofi Pasteur) administered concomitantly with Rotarix and Prevnar 13 at 2 and 4 months of age  (Hib-MenCY-TT-016). “   The study will begin by October 31, 2013.  The study will be completed by July 31, 2016.  The final study report will be submitted by December 15, 2016. 

CMC PMCs:

2. ----b(4)--------------------------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

3. ----b(4)------- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

5.         -----b(4)--- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

6.         ----b(4)---- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

7.         ----b(4)--- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

8. ---b(4)--- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

----b(4)--- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------