MenQuadfi
BL: 125701
Proper Name: Meningococcal (Groups A, C, Y, W) Conjugate Vaccine
Tradename: MenQuadfi
Manufacturer: Sanofi Pasteur, Inc.
Indication:
- MenQuadfi is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi is approved for use in individuals 2 years of age and older.
- MenQuadfi does not prevent N. meningitidis serogroup B disease.
Product Information
- Package Insert - MenQuadfi
- Demographic Subgroup Information – Meningococcal (Groups A, C, Y, W) Conjugate Vaccine (MenQuadfi)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- June 9, 2023 Approval Letter - MenQuadfi
- June 16, 2022 Approval Letter - MenQuadfi
- October 27, 2021 Approval Letter - MenQuadfi
- April 23, 2020 Approval Letter - MenQuadfi
- April 22, 2020 Summary Basis for Regulatory Action - MenQuadfi
- March 27, 2020 Statistical Review - MenQuadfi
- Approval History, Letters, Reviews, and Related Documents - MenQuadfi