
Record of Telephone Conversation, November 30, 2012 - Flublok

 
 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR

Product:

Influenza Vaccine

Applicant:

Protein Sciences Corporation

Telecon Date/Time: 30-Nov-2012 02:49 PM        Initiated by FDA? Yes

Telephone Number: Communicated via e-mail

Communication Categorie(s):

1. Advice

Author: TIMOTHY FRITZ

Telecon Summary:

Potential list of postmarketing studies.

FDA Participants: Timothy Fritz

Non-FDA Participants: Penny Post, Manon Cox

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

From:                    Fritz, Timothy

Sent:                      Friday, November 30, 2012 2:49 PM

To:                         'Penny Post'

Cc:                         Manon Cox

Subject:                 Potential postmarketing studies for STN 125285 (Flublok)

 

Importance:           High

Dear Dr. Post-

 

We are currently determining the postmarketing requirements/commitments that will be associated with the Flublok BLA (STN 125285) and want to inform Protein Sciences Corporation (PSC) of the studies being considered for your planning purposes. It is important to note that the following list is preliminary and may be incomplete and that we have not reached a final determination for the studies to be conducted. Please also note that, for the final study list agreed upon between CBER and PSC, PSC will need to provide dates for study protocol submission, study initiation and completion and final study report submission.

 

Postmarketing Requirements

 

1. Deferred pediatric study under PREA to evaluate the safety, reactogenicity and immunogenicity of Flublok in children 6-17 years of age.

 

2. Deferred pediatric study under PREA to evaluate the safety, reactogenicity and immunogenicity of Flublok in healthy children 3-5 years of age.

 

Postmarketing Commitments

 

3. Large, Phase 4 observational safety and immunogenicity study (PSC07/09) in adults 18-49 years old.

 

4. Establishment of a Flublok pregnancy registry.

 

 

If you have any questions, please contact the Regulatory Project Chair, Dr. Timothy Fritz, at 301-796-2640.

 

Thank you.

Timothy A. Fritz, Ph.D. 
Microbiologist 
FDA/CBER/OVRR/DVRPA/CMC2 
WOC2 HFM-478
1451 Rockville Pike 
Rockville, MD 20852 
Phone: 301-796-2640 
Fax: 301-827-1597

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