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Vaccines, Blood & Biologics
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Resources for You
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Menactra
Proper Name: Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Tradename: Menactra
Manufacturer: Sanofi Pasteur Inc, License #1725
Indications:
- Expanded age indication for subjects 2-10 years of age.
- To include a single dose syringe presentation.
- Active immunization of adolescents and adults 11-55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
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Supporting Documents
- August 3, 2009 Approval Letter - Menactra
Revise Package Insert: To include changes to the package insert regarding formaldehyde levels. - October 7, 2008 Approval Letter-Menactra
Revised Package Insert : To include changes to the package insert to incorporate post-marketing safety information regarding anaphylaxis. - October 18, 2007 Approval Letter
Indication: Expanded age indication for subjects 2-10 years of age. - FDA Expands Age Range for Use of Bacterial Meningitis Vaccine
Press Release: 10/18/2007 - March 30, 2007 Approval Letter - Menactra
Indication: To include a single dose syringe presentation. - January 14, 2005 Approval Letter
Indication: Active immunization of adolescents and adults 11-55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. - Menactra Clinical Review - (Part 1) (PDF - 1500KB)
Clinical Review of New Biologics License Application STN# 125089-Menactra Date of submitted application: 12-1 8-03. - Menactra Clinical Review - (Part 2) (PDF - 1694KB)
Comparative Safety and Immunogenicity Study in Adults 18-55 year old Clinical Study - MTA-09 - Menactra Clinical Review- (Part 3) (PDF - 1558KB)
Lot Consistency in Adults 18-55 years old Clinical Study - MTA-14
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