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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852-1448
October 17, 2005
Our Submission Tracking Number (STN): BL 103475/5090
Judith A. Magner, M.S.
GlaxoSmithKline Biologicals
2301 Renaissance Blvd.
P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Ms. Magner:
We have approved your request to supplement your biologics license application for Hepatitis A Vaccine, Inactivated (Havrix), to include package insert labeling changes to support lowering the age indication for Havrix from two years to 12 months of age. We will include information contained in the above-referenced supplement in your biologics license application file.
We acknowledge the post-marketing clinical commitments outlined in your submission dated October 14, 2005 as follows:
- You have agreed to evaluate the safety of administering two doses of Havrix six months apart in at least 3000 children 12 to 23 months of age.
- You have agreed to conduct an open, randomized, controlled study to evaluate safety and immunogenicity of concurrent administration of Havrix (720 EL.U./0.5 mL dose) with Prevnar in healthy children 12 to 15 months of age. The safety data for children administered two doses of Havrix in this study may be included as part of your commitment to assess safety in at least 3000 children 12 to 23 months of age. We acknowledge that the study has been initiated, and the final study report will be submitted to CBER by December, 2006.
- You have agreed to conduct an open, randomized, controlled study to evaluate safety and immunogencity of concurrent immunization of Havrix (720 EL.U./0.5 mL dose) with MMRII and Varivax in healthy children 12 to 15 months of age. The safety data for children administered two doses of Havrix in this study may be included as part of your commitment to assess safety in at least 3000 children 12 to 23 months of age. We acknowledge that the study has been initiated and the final study report will be submitted to CBER by March, 2008.
- You have agreed to conduct an open, randomized, controlled study to evaluate safety and immunogencity of concurrent immunization of Havrix (720 EL.U./0.5 mL dose) with Infanrix and ActHIB in healthy children 12 to 15 months of age. The safety data for children administered two doses of Havrix in this study may be included as part of your commitment to assess safety in at least 3000 children 12 to 23 months of age. We acknowledge that the study has been initiated and discussions are ongoing with CBER regarding potential revisions to the study protocol. The final study report will be submitted to CBER by September, 2011.
The status of the required post-marketing commitments should be reported annually according to 21 CFR 601.70.
All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric subjects unless this requirement is waived or deferred. The data provided in this supplement are sufficient to assess the safety and effectiveness of Havrix for the claimed indication in individuals 12 months of age and older. Studies demonstrating safety and effectiveness of Havrix in individuals less than 12 months of age are deferred
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Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as one original paper copy.
Sincerely yours,
--- signature ---
Karen L. Goldenthal, M.D.
Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
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