Vaccines:

Indications for: MENQUADFI

Meningitis immunization.

Clinical Trials:

Primary Vaccination

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.

 

Booster

  • 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.

Adults and Children:

<2yrs: not established. Give by IM inj only. Primary vaccination: ≥2yrs: 0.5mL once as single inj. Booster vaccination: ≥15yrs: may give a single (0.5mL) dose for those at continued risk, if at least 4yrs have elapsed since the prior dose.

MENQUADFI Contraindications:

Severe allergic reaction after a previous dose of MenQuadfi or any other tetanus toxoid-containing vaccine.

MENQUADFI Warnings/Precautions:

Not for the prevention of N. meningitidis serogroup B disease. Not a substitute for routine tetanus immunization. Have epinephrine inj (1:1000) available. History of Guillain-Barre syndrome. Immunosuppressed. Complement deficiency. Eculizumab therapy. Risk of syncope. Pregnancy. Nursing mothers.

MENQUADFI Classification:

Meningitis vaccine.

MENQUADFI Interactions:

Immunosuppressants may get suboptimal response. Concomitant other vaccines: see full labeling.

Adverse Reactions:

Inj site reactions (pain, erythema, swelling), myalgia, headache, malaise.

Note:

To enroll pregnant patients or obtain information call (800) 822-2463.

Generic Drug Availability:

NO

How Supplied:

Single-dose vials—5