Menactra: Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine

Menactra
Proper Name: Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Tradename: Menactra
Manufacturer: Sanofi Pasteur Inc, License #1725


-Product Information
Package Insert - Menactra (PDF - 327KB)
Updated: 5/2009

--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

abrir aquí para acceder a los documentos FDA descriptos previamente que explicitan las condiciones clínicas e inmunológicas de la vacuna conjugada:
Menactra