Clinical Review of KINRIX Biologics License Application: Post-marketing Study Commitment

Date:	June 19, 2008
From:	Karen M. Farizo, M.D. Medical Officer Vaccines Clinical Trials Branch Division of Vaccines and Related Product Applications Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration
Subject:	Clinical Review of KINRIX Biologics License Application: Post-marketing Study Commitment
To:	BLA STN# 125260
Through:	Lucia Lee, M.D. Team Leader, Vaccines Clinical Trials Branch Division of Vaccines and Related Products Applications Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration
cc:	Michael Schmitt, PhD Joseph Temenak, PhD

The January 31, 2008 clinical review of the KINRIX Biologics License Application described the applicant's post-marketing commitment to conduct a randomized, open label, comparative trial to evaluate the immunogenicity and safety of KINRIX administered concomitantly with varicella vaccine. A control group will receive KINRIX and varicella vaccine at separate visits. Data on concomitant administration of KINRIX with varicella vaccine were not available from the pre-licensure clinical trials because the trials were conducted prior to recommendations to administer a second dose of varicella vaccine in children 4-6 years of age.

In view of the FDA Amendments Act of 2007 (FDAAA) Title IX Section 901, it is important to clarify that the proposed post-marketing clinical trial will be conducted primarily to evaluate the immunogenicity of KINRIX administered concomitantly with varicella vaccine. While trial participants will be monitored for safety post-vaccination, the primary objectives and endpoints of the trial will pertain to the immune responses following KINRIX. The trial is not being planned to assess any serious risk, signals of serious risk, or the potential for serious risk. For these reasons, the planned trial is not considered a post-marketing requirement under FDAAA.

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