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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

October 18, 2007 Approval Letter

October 18, 2007

Our STN: BL 125089/2

Sanofi Pasteur Inc.
Attention: Gary Chikami, M.D.
Discovery Drive
Swiftwater, PA 18370-0187

Dear Dr. Chikami:

We have approved your request to supplement your biologics license application for Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra®) to include an expanded age indication for subjects 2-10 years of age, in addition to your current age indication of 11-55 years of age.

This fulfills your commitment to submit a BLA supplement to establish the safety and effectiveness of Menactra vaccine in subjects 2-10 years of age as stated in commitment number 1 of the January 14, 2005, approval letter.

We acknowledge your written commitments as described in your August 29, 2007, submission, as outlined below:

Postmarketing Studies subject to reporting requirements of 21 CFR 601.70.

  1. Under this approval, Menactra vaccine has been shown to be non-inferior to Menomune®-A/C/Y/W-135 vaccine in children 2-10 years of age. However, you have agreed to evaluate whether any subgroups within this age range would derive additional immunologic benefit from a second dose of Menactra vaccine. The complete study protocol for the trial described in your August 7, 2007, concept protocol will be submitted by January 2008. The study will be initiated by June 2008. The final study report will be submitted 1 year after the last subject has completed the study. You have agreed to conduct confirmatory study(ies) by June 2010. The final study report for any additional study will be submitted 1 year after the last subject has completed the study.
  2. You have agreed to conduct an open label, descriptive, epidemiological safety surveillance study of Menactra vaccine in subjects 2-10 years of age following licensure in this age range. The study will include two parts. Part I of the study will begin with the first administration of Menactra vaccine to a child 2 to 10 years of age (inclusive) who receives medical care at the site where the study is being conducted. Part I will continue for 3 years, or until commencement of Part II, whichever occurs first. Part II of the study will be initiated if there is a recommendation by the Advisory Committee on Immunization Practices (ACIP) for routine use of Menactra vaccine in at least one birth cohort within the 2-10 year age range.

    Part II will commence with the effective date of the ACIP recommendation, and will continue until 20,000 children are enrolled, or until 1 year has elapsed, whichever occurs last. The final study report for Part I will be submitted 1 year after the last subject has completed study Part I. If initiated, a final study report for Part II will be submitted 1 year after the last subject has completed study Part II.

  3. In addition to complying with the requirements under 21 CFR 600.80, you have agreed to submit as 30 day (monthly) reports for one year following licensure of Menactra® in subjects 2-10 years of age: all allergic events, including anaphylaxis and urticaria, not reported as a 15 day report; neurological events not reported as 15 day reports, including Bell's palsy, Guillain-Barré syndrome, encephalitis, encephalopathy, brachial neuritis, optic neuritis, other neuropathy, myelitis including transverse myelitis, ptosis, ataxia, and acute disseminated encephalomyelitis; and new-onset autoimmune disease, including ITP, diabetes, arthritis, hemolytic anemia, and collagen-vascular disease not reported as a 15 day report.

Please submit clinical protocols to your IND, with a cross-reference letter to this biologics license application (BLA), STN BL 125089/2. Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to your BLA STN BL 125089/0. If the information in the final study report supports a change in the labeling, the final study report should be submitted as a supplement. We may also request a supplement if we think labeling changes are needed. Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:

  • Postmarketing Study Protocol
  • Postmarketing Study Final Report
  • Postmarketing Study Correspondence
  • Annual Report on Postmarketing Studies

For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for this product. The status report for each study should include:

  • information to identify and describe the postmarketing commitment,
  • the original schedule for the commitment,
  • the status of the commitment (i.e. pending, ongoing, delayed, terminated, or submitted), and
  • an explanation of the status including, for clinical studies, the patient accrual rate (i.e. number enrolled to date and the total planned enrollment).

As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our Internet site (http://www.fda.gov/cder/pmc/default.htm). For further information, please refer to the April 2001 Draft Guidance for Industry: Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (see http://www.fda.gov/cber/gdlns/post040401.htm).

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.

---------------------------------------------------------------------------------------------- --------------------------------------------------------------------------------------------- --------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------- -------------------------------

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy. In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448. Please submit your final printed advertising at the time of initial publication and your final promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

--- signature ---

Janice M. Soreth, M.D.
Director (Acting)
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling


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