RECORD OF E-MAIL COMMUNICATION
Submission Type: Original Application Submission ID: 125347/0 Office: OVRR
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Telecon Date/Time: 14-JUL-2009 10:00 AM Initiated by FDA? Yes
Labeling via FAX/e-mail
Author: JASON HUMBERT
Additional comments related to the revised PI submitted July 10, 2009
FDA Participants: Jason Humbert
Non-FDA Participants: Elisa Harkins, GSK
Telecon Body: The following two comments were conveyed to GSK via e-mail:
1. Page 7, Under Section 11 Description, Lines 164-171: We recommend the following changes:
toxoid toxin, prepared from Clostridium tetani grown in a semi-synthetic medium, is detoxified and purified. The capsular polysaccharide is covalently bound to the inactivated tetanus toxoid. After purification, the conjugate is lyophilized in the presence of lactose as a stabilizer. The diluent for HIBERIX is a sterile saline solution (0.9% sodium chloride) supplied in prefilled TIP-LOK syringes.
When HIBERIX is reconstituted with the accompanying saline diluent, each 0.5-mL dose is formulated to contain 10 mcg of purified capsular polysaccharide conjugated to approximately 25 mcg of
inactivated tetanus toxoid, and 12.6 mg of lactose.
2. Page 9, Line 247: Please delete “-1035”.