Menquadfi Generic Name & Formulations
Mechanism of Action
Menquadfi Dosage and Administration
Adults and Children
Menquadfi Boxed Warnings
Management of Acute Allergic Reactions
Have medical treatment readily available in case of an anaphylactic event following administration.
May reduce immune responses in some individuals with altered immunocompetence, including those receiving immunosuppressant therapy.
Increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, Y and W-135, in persons with certain complement deficiencies and those receiving treatment that inhibits terminal complement activation (eg, eculizumab) even if they develop antibodies following vaccination with MenQuadfi.
Syncope may occur. Procedures should be in place to avoid injury from fainting and manage syncope.
Consider the potential benefits and risks of administering MenQuadfi in persons with a history of Guillain-Barré Syndrome (GBS).
Temporal relationship has been reported with GBS following administration of Menactra.
MenQuadfi does not substitute for routine tetanus immunization.
Limitations of Vaccine Effectiveness
May not protect all vaccine recipients.
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MenQuadfi during pregnancy. To enroll in or obtain information about the registry, call Sanofi Pasteur at 1-800-822-2463.
No clinical studies are available for MenQuadfi administration in pregnant women.
Available human data on MenQuadfi are insufficient to inform vaccine-associated risks in pregnancy.
Nursing Mother Considerations
Unknown whether MenQuadfi is excreted in human milk.
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for MenQuadfi and any potential adverse effects on the breastfed child from MenQuadfi.
Safety and efficacy of MenQuadfi have not been established in individuals younger than 2 years of age in the US.
Concomitant Administration with Other Vaccines
In a clinical trial in adolescents 10 through 17 years of age, MenQuadfi was administered concomitantly with Tdap and HPV.
When MenQuadfi was co-administered with Tdap and HPV, lower geometric mean antibody concentrations (GMCs) for antibodies to the pertussis antigens filamentous hemagglutinin (FHA), pertactin (PRN) and fimbriae (FIM) were observed compared to concomitant administration of Tdap and HPV (without MenQuadfi).
Immunosuppressive therapies may reduce the suboptimal response.
Menquadfi Adverse Reactions
Most commonly reported adverse reactions (≥10%) following a primary dose were as follows:
Children 2 through 9 years of age: pain (38.6%), erythema (22.6%), and swelling (13.8%) at the injection site; malaise (21.1%), myalgia (20.1%), and headache (12.5%).
Adolescents aged 10 through 17 years of age: injection site pain (34.8%– 45.2%), myalgia (27.4%–35.3%), headache (26.5%–30.2%), and malaise (19.4%–26.0%).
Adults aged 18 through 55 years: injection site pain (41.9%), myalgia (35.6%), headache (29.0%), and malaise (22.9%).
Adults 56 years of age and older: pain at the injection site (25.5%), myalgia (21.9%), headache (19.0%), and malaise (14.5%).
In adolescents and adults, rates of solicited adverse reactions following a booster dose were comparable to those observed following primary vaccination.
Menquadfi Clinical Trials
Immunogenicity in Children 2 through 9 Years of Age
Study 1 (NCT03077438) – The immunogenicity of MenQuadfi was compared to Menveo in participants 2 through 9 years of age. MenQuadfi achieved noninferiority to Menveo for seroresponse rates for all 4 serogroups.
Immunogenicity in Adolescents 10 through 17 Years of Age
Study 2 (NCT02199691) – The immunogenicity of MenQuadfi was compared to Menveo in healthy meningococcal vaccine naïve participants 10 through 17 years of age. Participants received either MenQuadfi alone, Menveo alone, MenQuadfi co-administered with Tdap, and HPV, or Tdap and HPV alone. MenQuadfi achieved noninferiority to Menveo for seroresponse rates for all 4 serogroups.
Study 3 (NCT02842853) – The immunogenicity of MenQuadfi was compared to Menactra in healthy meningococcal-naïve participants 10 through 17 years of age. Seroresponse rates for MenQuadfi were noninferior to Menactra for all serogroups.
Immunogenicity in Adults 18 through 55 Years of Age
Study 3 (NCT02842853) – The immunogenicity of MenQuadfi was compared to Menactra in participants 18 through 55 years of age. Seroresponse rates for MenQuadfi were noninferior to Menactra for all serogroups.
Immunogenicity in Adults 56 Years of Age and Older
Study 4 (NCT02842866) – The immunogenicity of MenQuadfi was compared to Menomune in participants 56 years of age and older. Seroresponse rates for MenQuadfi were noninferior to Menomune for all serogroups.
Study 5 (NCT02752906) – The immunogenicity of a booster dose of MenQuadfi was compared to a booster dose of Menactra in participants 15 years of age and older who previously received a primary dose of Menveo or Menactra 4 to 10 years prior. Seroresponse rates for MenQuadfi were noninferior to Menactra for all serogroups.
Menquadfi Patient Counseling
Inform the patients, parents or guardians about:
Potential benefits and risks of immunization with MenQuadfi.
Potential for adverse reactions that have been temporally associated with administration of MenQuadfi or other vaccines containing similar components.
Reporting any adverse reactions to their healthcare provider.
The Sanofi Pasteur Inc. Pregnancy Registry, as appropriate.