Submission Type: BLA Submission ID: 125363/0 Office: OVRR Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 10-Dec-2009 10:00 AM Initiated by FDA? No
Telephone Number: Communication Category:
Author: JASON HUMBERT Telecon Summary:
Telecon requested by GSK to discuss 12/2 information request
FDA Participants: Joe Temenak Barbara Krasnicka Lucia Lee
Non-FDA Participants: Jody Gould
GSK requested this teleconference to discuss the information request dated December 2, in which CBER asked the following:
1. We request that you remove subjects administered Lot A during the fourth dose phase (Hib-MenCY-TT-010) from the fourth dose pivotal immunogenicity analyses (i.e., within group data and between group differences in: a) anti-PRP greater than or equal to
0.15 mcg/mL and 1 mcg/mL and GMCs post-4th dose; b) hSBA-MenC and hSBA-MenY titers greater than or equal to 1:4 and 1:8 and GMTs post-4th dose; c) ratios of the anti- PRP GMCs between HibMenCY-TT and Hib); d) MMR and V endpoints. Please also provide the corresponding safety analyses without subjects who received Lot A Hib- MenCY-TT vaccine.
If only Lot B or C or Lots B + C were administered during the 4th dose phase, the information as presented in the original BLA submission is sufficient for the post-4th
2. We request that you provide demographic information for Lots B + C
combined for Hib-MenCY-TT-010 or by individual lot as done for Hib-MenCY-TT-009.
3. Regarding the "List of Reactogenicity/Safety Tables to Generate", we request that the data on solicited adverse events be presented both on the Total Vaccinated Cohort (TVC) corrected by country and on the TVC by individual country.
GSK clarified that only one lot is used in the 4th dose phase of the study, and it was not a lot used in the primary phase of the pivotal U.S. immunogenicity and lot-to-lot consistency study, Hib-MenCY-TT-009. The lot used in the 4th dose phase of the study, Hib-MenCY-TT-010, was used in Study Hib-MenCY-TT-012, which was a safety study
with no blood draws to evaluate immunogenicity. GSK stated that they can perform additional analyses as requested, but questioned whether the information obtained would be beneficial to CBER.
CBER agreed that in light of the information provided during this call, the analyses requested for the 4th dose phase of the study would not be beneficial at this point. We will discuss other alternatives internally and contact GSK with further requests, if necessary. CBER affirmed that the additional analyses of data from the primary phase of the study, Hib-MenCY-TT-009, requested on October 21, 2009 may be helpful and should be
No other issues were discussed and the call concluded.