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April 22, 2011 Approval Letter - Menactra

Our STN: BL 125089/395
 
Sanofi Pasteur Inc.
Attention: Joseph H. Quinn
Discovery Drive
Swiftwater, PA 18370-0187
 
Dear Mr. Quinn:
 
We have approved your request to supplement your biologics license application (BLA) for Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra), to include safety and immunogenicity data to support use in children 9 through 23 months of age to prevent invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W-135.
 
The review of this product was associated with the following National Clinical Trial number: 00384397.
 
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. In addition, please submit three original paper copies for carton and container final printed labeling. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.
 
In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation
/Guidances/UCM072392.pdf
.
 
You may submit two 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, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).
 
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).
 
Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes this change.
 
PEDIATRIC REQUIREMENTS
 
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.
 
Studies MTA-44 and MTA-48 fulfill the pediatric requirement to evaluate the safety and immunogenicity of Menactra when administered to children less than 2 years of age as stated in requirement number 2 of the January 14, 2005, approval letter.
 
We note that you have fulfilled the pediatric study requirement for all relevant pediatric age groups for this application.
 
We are waiving the pediatric study requirement for ages 0 through 8 months of age because there is evidence strongly suggesting that Menactra would be ineffective in this age group.
 
AGREED UPON POSTMARKETING COMMITMENTS
 
Postmarketing Studies subject to reporting requirements of 21 CFR 601.70
 
We acknowledge your written commitment as described in your amendments of April 20, 2011, and April 22, 2011, as outlined below:
 

1.  Sanofi Pasteur will conduct a Phase II open-label administration (laboratory personnel will be blinded to group assignment) parallel-group, multicenter study to evaluate the safety and immunogenicity of two doses of Menactra when administered alone at 9 months and concomitantly with Pentacel® at 15 to 18 months of age, entitled, "Immunogenicity and Safety Evaluation of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered to Healthy Subjects at 9 Months and Concomitantly with Pentacel® at 15 to 18 Months of Age, (MTA55)."
 

  • The concept protocol will be submitted in April 2011. 
  • The study protocol will be submitted in August 2011.
  • The study will be initiated in February 2012, and completed by June 2014.
  • There is no formal interim report planned for this study. 
  • The final study report will be submitted in November 2014.
     
2.   Sanofi Pasteur will conduct a Phase IV, descriptive, epidemiological, safety surveillance study in the United States, entitled, Post-licensure Safety Surveillance Study of Menactra® Vaccine When Administered as a 2-dose Schedule to Children 9 Months through Months of Age,(MTA57)." This study will be conducted in two stages:

 
  • Stage I will be considered to have started with the first administration within Kaiser Permanente Medical Care Program to an individual 9 months through 23 months of age. Two doses of Menactra would be administered three months apart, with the first dose given at 9 months to less than 12 months of age, at 12 months to less than 18 months of age, or at 18 months to less than 24 months of age. The study will continue until one of the following conditions is met: 1) approximately 3000 persons (approximately 1000 persons in each age cohort) have received a 2-dose series, 2) the effective date of a recommendation issued by the Advisory Committee on Immunization Practices (ACIP) for routine use of Menactra vaccine as a 2-dose series in children 9 through 23 months of age, or 3) three years have elapsed, whichever occurs first.

  • Stage II will commence with the effective date of an ACIP recommendation for routine use of Menactra in children 9 months through 23 months of age (if such recommendation occurs before 3 years have elapsed following FDA approval of Menactra use in children 9 months through 23 months of age), and will continue until 20,000 persons with first vaccination at 9 months through 23 months of age have come under surveillance, or until 1 year has elapsed, whichever occurs last. In the event that there is no recommendation for routine use of meningococcal vaccine in this age group, Stage II will be considered fulfilled when Stage I is completed.

    • The concept protocol will be submitted in May 2011.
    • The study protocol will be submitted in June 2011.
    • The study will be initiated in August 2011, and completed by December 2014.
    • The final study report will be submitted in March 2016.
       
    Please submit clinical protocols to your IND --b(4)--, with a cross-reference letter to this supplement to your BLA, STN 125089/395. Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to your BLA, STN 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 Commitment Protocol
    • Postmarketing Study Correspondence
    • Postmarketing Study Commitment – Final Study Report
    • Supplement Contains Postmarketing Study Commitments – Final Study Report
     
    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. Label your annual report an “Annual Status Report of Postmarketing Study Commitments.” 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 Web site (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm). Please refer to the February 2006 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/downloads/Drugs/GuidanceComplianceRegulatoryInformation
    /Guidances/UCM080569.pdf
    ) for further information.  We will include information contained in the above-referenced supplement in your BLA file.

     
    Sincerely yours,
     
    Wellington Sun, M.D.
    Director
    Division of Vaccines and Related Products Applications
    Office of Vaccine Research and Review
    Center for Biologics Evaluation and Research
     
Attachment: Approved Final Draft Labeling