Submission Type: Original Application Submission ID: 125363/0 Office: OVRR Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 02-DEC-2009 12:30 PM Initiated by FDA? Yes
Communication Category(s): Information Request
Author: JASON HUMBERT Telecon Summary:
Comments and requests for additional information regarding proposed analyses submitted via e-mail on Oct. 30, 2009.
FDA Participants: Jason Humbert, RPM
Non-FDA Participants: Jody Gould, PhD GSK
The following e-mail was provided to GSK:
Good afternoon Jody,
We have reviewed the document provided in an October 30, 2009 e-mail which was a response to our request for immunogenicity analyses and analyses of solicited and unsolicited adverse events (with corresponding comparisons to the control group) for
Hib-MenCY-TT lots B and C combined separately from Hib-MenCY-TT lot A. Based on our review of what you have proposed, we have the following comments:
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.
If you have any questions, please do not hesitate to contact me. Thank you.
Regulatory Project Manager
Division of Vaccines and Related Product Applications
Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration
Tel: (301) 827-6019
Fax: (301) 827-3532