Menactra

Proper Name: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Menactra is a sterile, intramuscularly administered vaccine that contains N meningitidis serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein.

Advisory Board:

Did not require input from Vaccines and Related Biological Products Advisory Committee.

Indications: 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.

Key Regulatory Milestones:

2005 – Menactra was licensed for use and distribution in the US in for individuals 11 through 55 years of age.

2007 – the age range for use was extended to include persons 2 through 10 years of age.

2011 – approved for use in children 9 through 23 months of age.

9/16/2016 – PDUFA Goal Date

04/27/2018 – FDA approval date

Package Insert