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Vaccines, Blood & Biologics

1/8/2008 Email - Rotarix

From: Henchal, Laraine

Sent: Tuesday, January 08, 2008 10:31 AM

To: ''

Cc: Vujcic, Luba

Subject: Info request for STN#125265/0

Attachments: Picture (Metafile); Picture (Metafile); Picture (Metafile)

Hi Donna,

Some additional request for information from the review team:

1.) On page 88 of your Rota023 year 1 report, you state that you also performed the Cox proportional-hazard model on the data and "Results of analysis using the Cox proportional-hazard model are available on file at GSK Biologicals, Rixensart." Please submit this analysis to your BLA as soon as possible.

2.) In your Reporting and Analysis Plan for Rota-023, you state:

statement in the Reporting and Analysis Plan for Rota-023
statement in the Reporting and Analysis Plan for Rota-023
statement in the Reporting and Analysis Plan for Rota-023

Since changing the primary objective of an ongoing trial may affect the integrity of the study and thus must be done with caution, please provide more information on how the decision was made, what the procedures are of making such a change, and the names of all regulatory agencies that concurred with this change. Please respond.

3.) In regard to the Diphtheria and Tetanus serology assays, we have the following requests. We note that this information was provided to STN ---------------- on -----------------, so the information provided there can be cross referenced, if applicable, for this STN:

a. For each critical reagent used in the Diphtheria and Tetanus ELISAs, please submit a summary of the data generated to qualify the batch(es) used in the assays presented in this submission.

b. Please submit data which supports the precision of the Diphtheria and Tetanus ELISAs over their entire working ranges and indicate the specific GMC/GMT range of samples used to determine assay precision.

Laraine S. Henchal, MAS
Microbiologist Reviewer, Team Leader
Viral Vaccines Branch
Division of Vaccines and
Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Phone: 301-827-3070
Fax: 301-827-3532

Contact FDA

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(240) 402-8010
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