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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
August 11, 2005
Submission Tracking Number (STN): BL 103606 / 5049
Angela Howard, Ph.D.
Merck & Co., Inc.
P.O. Box 4, UN-B121
West Point, PA 19486
Dear Dr. Howard:
The Supplement to your License Application for Hepatitis A Vaccine, Inactivated (VAQTA), to include package insert labeling changes to support lowering the age indication for VAQTA from two years to 12 months of age, has been approved. This information will be included in your License Application File.
We acknowledge the post-marketing clinical commitments outlined in your submissions dated May 13, 2005 and May 17, 2005, as follows:
- You have agreed to evaluate the safety of administering two doses of VAQTA six months apart in 3000 additional children 12 to 23 months of age.
- As part of your commitment to increase the size of your safety database for VAQTA in younger children, you have agreed to conduct an open-label, multicenter clinical trial to evaluate the safety and tolerability of two doses of VAQTA in a total of 2,260 children 12 to 23 months of age. The final study protocol will be submitted by October, 2005. The study will be initiated no later than May, 2006 and the final study report will be submitted to CBER by September, 2008.
- You have agreed to conduct an open, randomized study to
evaluate safety and immunogenicity of concurrent administration of VAQTA with ProQuad and Prevnar in healthy children 12 months of age. The safety data for children administered two doses of VAQTA in this study may be included as part of your commitment to assess safety in 3000 additional children 12 to 23 months of age. The final study protocol will be submitted by October, 2005. The study will be initiated no later than April, 2006 and the final study report will be submitted to CBER by September, 2008.
- You have agreed to conduct an open, randomized study to
evaluate safety and immunogencity of concurrent immunization of VAQTA with PedvaxHIB and concurrent immunization of VAQTA with DTaP vaccine in healthy children 15 months of age. The safety data for children administered two doses of VAQTA in this study may be included as part of your commitment to assess safety in 3000 additional children 12 to 23 months of age. The final study protocol will be submitted by October, 2005. The study will be initiated no later than March, 2006 and the final study report will be submitted to CBER by September, 2008.
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 patients unless this requirement is waived or deferred. The data provided in this supplement are sufficient to assess the safety and effectiveness of VAQTA for the claimed indication in individuals 12 months of age and older. Studies demonstrating safety and effectiveness of VAQTA in individuals less than 12 months of age are deferred as the clinical development in this age range, to include an assessment of the safety and effectiveness of VAQTA administered with routinely recommended U.S. licensed vaccines given to children less then 12 months of age, is under development.
Please submit three copies of final printed labeling, at the time of use and include the label transmittal Form FDA 2567 with completed implementation information.
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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