Meningococcal

MenQuadfi by Sanofi Pasteur (Meningococcal ACWY)

Captured 2022-12-06
Document Highlights

Initial U.S. Approval: 2020

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.

Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine.

Children 2 through 9 years of age
SAEs [Serious Adverse Events] occurred at a rate of 1.4%

Adolescents 10 through 17 years of age
SAEs occurred at a rate of 0.8%

Adults 18 through 55 years of age
SAEs occurred at a rate of 1.6%

Adults 56 years of age and older
SAEs occurred at a rate of 3.3%

MenQuadfi is a sterile liquid vaccine administered by intramuscular injection that contains Neisseria meningitidis serogroup A, C, W, and Y capsular polysaccharide antigens that are individually conjugated to tetanus toxoid protein.

Each 0.5 mL dose of vaccine contains 10 microgram each of meningococcal A, C, W, and Y polysaccharide antigens conjugated to approximately 55 micrograms tetanus toxoid protein carrier; 3.35 mg sodium chloride (0.67%), and 1.23 mg sodium acetate (30 mM).

MenQuadfi has not been evaluated for carcinogenic or mutagenic potential or for impairment of male fertility.

Comments

No postmarketing data on adverse events is listed on the MenQuadfi insert as of March 2023.

MenQuadfi was not tested for safety in a placebo-controlled clinical trial.

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