Currently Enrolling Trials
MenQuadfi (Meningococcal [Groups A, C, Y, W] Conjugate Vaccine) is a sterile liquid vaccine that contains Neisseria meningitidis serogroup A, C, W, and Y capsular polysaccharide antigens that are individually conjugated to tetanus toxoid protein.
MenQuadfi is specifically indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi is indicated for use in individuals 2 years of age and older.
MenQuadfi is supplied as a solution for intramuscular administration. Administer MenQuadfi as a single 0.5 mL injection intramuscularly.
- Primary Vaccination: Individuals 2 years of age and older receive a single dose.
- Booster Vaccination: A single dose of MenQuadfi may be administered to individuals 15 years of age and older who are at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of meningococcal (Groups A, C, W, Y) conjugate vaccine.
Mechanism of Action
MenQuadfi (Meningococcal [Groups A, C, Y, W] Conjugate Vaccine) is a sterile liquid vaccine that contains Neisseria meningitidis serogroup A, C, W, and Y capsular polysaccharide antigens that are individually conjugated to tetanus toxoid protein. Invasive meningococcal disease (IMD) is caused by the bacterium N. meningitidis, a gramnegative diplococcus found exclusively in humans.The presence of bactericidal anti-capsular meningococcal antibodies in serum has been associated with protection from IMD. MenQuadfi induces the production of bactericidal antibodies specific to the capsular polysaccharides of N. meningitidis serogroups A, C, W, and Y.
Adverse effects following a primary dose of MenQuadfi may include, but are not limited to, the following:
Children 2 through 9 years of age:
- swelling at the injection site
Adolescents aged 10 through 17 years of age:
- injection site pain
Adults aged 18 through 55 years:
- injection site pain
Adults 56 years of age and older:
- pain at the injection site
In adolescents and adults, rates of solicited adverse reactions following a booster dose were comparable to those observed following primary vaccination.
Clinical Trial Results
The FDA approval of MenQuadfi (Meningococcal [Groups A, C, Y, W] Conjugate Vaccine) was based on clinical data from five double-blind, randomized, multicenter Phase 2 and 3 trials that assessed safety and immune responses following vaccination, with nearly 5,000 persons 2 years of age and older. Based on study objectives, immune responses elicited by MenQuadfi achieved non-inferiority compared to those induced by licensed quadrivalent meningococcal vaccines. Four studies evaluated MenQuadfi in meningococcal-naïve persons; the other study evaluated MenQuadfi in persons previously immunized with a quadrivalent meningococcal vaccine. Against each of the four meningococcal serogroups (A, C, W, Y), the majority (55.4%–97.2%) of meningococcal-naïve trial participants had a vaccine-induced immune response 30 days following vaccination with MenQuadfi. Among adolescents and adults previously vaccinated, 92.2%–98.2% demonstrated an immune response against each serogroup.