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Vaccines, Blood & Biologics

Record of E-mail Communication 2 - July 14, 2009

 

RECORD OF E-MAIL COMMUNICATION 

Submission Type: Original Application Submission ID: 125347/0 Office: OVRR 

Product: 
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) 

Applicant: 
GlaxoSmithKline Biologicals 

Telecon Date/Time: 14-JUL-2009 10:00 AM Initiated by FDA? Yes 
Telephone Number: 

Communication Category(s): 
Labeling via FAX/e-mail 

Author: JASON HUMBERT 

Telecon Summary: 
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: 

...The 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”.

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