Proper Name: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Manufacturer: Sanofi Pasteur Inc
- Active immunization of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.
- April 27, 2018 Approval Letter - Menactra
To revise the package insert labeling to include additional information in the ADVERSE EVENTS and WARNINGS AND PRECAUTIONS section.
- Final Clinical Review, September 14, 2016 - Menactra
Approved for use in individuals 9 months through 55 years of age. Menactra does not prevent N meningitidis serogroup B disease.
- September 16, 2016 Summary Basis of Regulatory Action - Menactra
- September 16, 2016 Approval Letter - Menanctra
To include immunogenicity and safety data to support the co-administration of Menactra with a fifth dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DAPTACEL) in children 4 through 6 years of age.
- September 4, 2014 Approval Letter - Menactra
To revise the package insert.
- September 3, 2014 Summary Basis for Regulatory Action - Menactra
- Supporting Documents older than three years - Menactra