Version May 2024
Meningococcal disease, prevention:
ACIP recommendations (Ref): Use of the abbreviation MenACWY refers to any meningococcal quadrivalent conjugate vaccine. MenACWY-CRM refers specifically to Menveo; MenACWY-D refers specifically to Menactra; MenACWY-TT refers specifically to MenQuadfi. Vaccines from different manufacturers are considered interchangeable; however, it is recommended (not required) that the same product be used for all doses.
Primary vaccination:
Routine for persons NOT at increased risk for meningococcal disease:
Adults 19 to 21 years of age: IM: Not routinely recommended; may receive one 0.5 mL dose as a catch-up vaccination if no dose was received after the sixteenth birthday.
Adults ≥22 years of age: Not routinely recommended; see dosing for persons at increased risk.
Routine for persons at increased risk for meningococcal disease:
Note: If using MenACWY-D (Menactra) for individuals with anatomic or functional asplenia or HIV, administer ≥4 weeks after completion of pneumococcal conjugate vaccine.
Adults not previously vaccinated who have functional or anatomic asplenia, HIV infection, persistent complement deficiencies (including complement deficiencies or complement inhibitor use [eg, eculizumab, ravulizumab]): IM: Two 0.5 mL doses, given ≥2 months apart.
Adults not previously vaccinated who are first-year college students living in residential housing; traveling to or residing in areas where meningococcal disease is endemic/hyperendemic; at risk during a community outbreak; military recruits; or microbiologists routinely exposed to N. meningitidis: IM: One 0.5 mL dose. College students should have documentation of a vaccination not more than 5 years before enrollment (preferably a dose on or after their sixteenth birthday).
Adults previously vaccinated with a single dose of MenACWY who later develop an underlying condition for which meningococcal 2-dose vaccination is recommended: IM: Administer second dose as soon as possible (≥8 week interval between doses); restarting the 2-dose series is not necessary.
Booster vaccination:
Persons NOT at increased risk for meningococcal disease (routine vaccination): Adults ≤21 years of age: IM: One 0.5 mL dose if the first dose was given prior to the sixteenth birthday. A booster dose is not needed if the primary dose was given after the sixteenth birthday unless the person becomes at increased risk for meningococcal disease.
Persons at increased risk for meningococcal disease: Repeat dose every 5 years if the person remains at increased risk.
Canadian National Advisory Committee on Immunization recommendations (Ref): Note: NACI recommendations do not yet reflect the approval of MenQuadfi.
Primary vaccination:
Routine:
Patients 12 to 24 years of age: IM: 0.5 mL as a single dose. Note: Routinely administered at 12 years of age, regardless if previously immunized as an infant or toddler. Administer either monovalent conjugate meningococcal vaccine (Men-C-C) or quadrivalent conjugate meningococcal vaccines (Men-C-ACYW); refer to provincial/local schedules.
Persons at increased risk for meningococcal disease who have not been previously vaccinated:
Adults at increased risk of disease due to underlying medical conditions (persistent complement deficiencies [including eculizumab use]; properdin, factor D, or primary antibody deficiencies; functional or anatomic asplenia; sickle cell disease, combined T- and B-cell immunodeficiencies; HIV infection): IM: Two 0.5 mL doses, given 8 weeks apart. Note: Doses may be administered ≥4 weeks apart if accelerated vaccination is needed.
Adults at increased risk of exposure (travelers to areas with high rates of endemic meningococcal disease or transmission; laboratory personnel routinely exposed to N. meningitidis): IM: 0.5 mL as a single dose.
Booster vaccination: Persons at increased risk for meningococcal disease: Repeat dose every 5 years if the person remains at increased risk.
Postexposure management (close contacts) or outbreak control (off-label use) (Ref): Recommendations dependent on meningococcal serogroup involved in exposure or outbreak:
Serogroup C:
Previously unvaccinated: IM: 0.5 mL/dose immediately after exposure (monovalent or quadrivalent vaccine may be used).
Previously vaccinated: IM: If vaccinated at <1 year of age or if at high risk for invasive meningococcal disease due to underlying medical condition, revaccinate with 0.5 mL/dose if ≥4 weeks since last dose; otherwise revaccinate if at least 1 year since last dose (monovalent or quadrivalent vaccine may be used).
Serogroup A, Y, or W-135:
Previously unvaccinated: IM: 0.5 mL/dose immediately after exposure; high-risk individuals with underlying medical conditions routinely require a total of 2 doses (administered at least 8 weeks apart or at least 4 weeks apart when more rapid immunization is needed).
Previously vaccinated: IM:
If previously vaccinated with only monovalent conjugate meningococcal group C vaccine (Men C-C), administer 0.5 mL/dose (quadrivalent vaccine) immediately after exposure, regardless of when Men C-C was given.
If previously vaccinated with quadrivalent vaccine at <1 year of age or if at high risk for invasive meningococcal disease due to underlying medical condition, revaccinate with 0.5 mL/dose (quadrivalent vaccine) if ≥4 weeks since last dose; otherwise re-vaccinate if at least 1 year since last dose.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Quadrivalent meningococcal conjugate vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT): Pediatric drug information")
Meningococcal disease, prevention:
ACIP recommendations (Ref): Note: Use of the abbreviation, MenACWY, refers to any meningococcal quadrivalent conjugate vaccine. MenACWY-CRM refers specifically to Menveo; MenACWY-D refers specifically to Menactra; MenACWY-TT refers specifically to MenQuadfi. Vaccines from different manufacturers are considered interchangeable; however, it is recommended (not required) that the same product be used for all doses. Consult CDC/ACIP annual immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (Ref).
Primary vaccination (Ref): Note: Although FDA approved in <11 years of age, use in patients <11 years is only recommended in those at increased risk; routine use not recommended by ACIP.
Patients NOT at increased risk for meningococcal disease:
Children 11 or 12 years: MenACWY-CRM (Menveo [1- or 2-vial formulation]), MenACWY-D (Menactra), or MenACWY-TT (MenQuadfi): IM: 0.5 mL as a single dose. Children not currently at increased risk for meningococcal disease who were previously vaccinated prior to their 10th birthday should receive the routinely recommended dose of MenACWY at 11 to 12 years. Children who received MenACWY at 10 years of age do not need an additional dose at 11 to 12 years.
Adolescents: MenACWY-CRM (Menveo [1- or 2-vial formulation]), MenACWY-D (Menactra), or MenACWY-TT (MenQuadfi): IM: 0.5 mL as a single dose if not previously vaccinated.
Patients at increased risk for meningococcal disease:
Note: MenACWY-D (Menactra) product should be avoided in patients <2 years of age due to interference with PCV-13 immunogenicity; if MenACWY-D must be used, administer it before or concomitantly with DTaP, and administer ≥4 weeks after completion of all PCV doses as age appropriate. Dosing schedules, including number of doses, intervals, and product preference vary based on patient age and reason for increased risk of meningococcal disease.
Infants ≥2 months and Children <2 years: Anatomic or functional asplenia (including sickle cell disease); HIV infection; persistent complement component deficiency (including complement inhibitor use [eg, eculizumab, ravulizumab]); an outbreak (due to a vaccine serogroup); or travel to or residence in countries with hyperendemic or epidemic meningococcal disease : Dosing based on age at initial dose.
Infants 2 to <3 months: MenACWY-CRM (Menveo [2-vial formulation]): IM: 0.5 mL per dose for a total of 4 doses administered at 2, 4, 6, and 12 months of age.
Infants 3 to 6 months: MenACWY-CRM (Menveo [2-vial formulation]): IM: 0.5 mL per dose at 8-week intervals for 1 or 2 doses until patient is ≥7 months of age; once patient ≥7 months of age, administer an additional dose; once patient ≥12 months of age and at least 12 weeks after the last dose, administer a final dose.
Infants and Children 7 to 23 months: Note: MenACWY-CRM (Menveo) preferred in patients with HIV infection or asplenia.
MenACWY-CRM (Menveo [2-vial formulation]): Infants and Children 7 to 23 months: IM: 0.5 mL per dose for a total of 2 doses; the second dose should be administered at age ≥12 months and at least 12 weeks after the first dose.
MenACWY-D (Menactra): Infants and Children 9 to 23 months: IM: 0.5 mL per dose for a total of 2 doses; the second dose should be administered at least 12 weeks after the first dose. May be given as early as 8 weeks apart if needed prior to travel. Note: Administer before or concomitantly with DTaP and ≥4 weeks after completion of all PCV doses.
Children 2 to <10 years (not previously vaccinated): Note: Administer MenACWY-D (Menactra) before or concomitantly with DTaP and ≥4 weeks after completion of all PCV doses; may be given at any time in relation to Tdap or Td.
Persistent complement deficiencies (including complement inhibitor use [eg, eculizumab, ravulizumab]); functional or anatomic asplenia; HIV infection: MenACWY-CRM (Menveo [2-vial formulation]), MenACWY-D (Menactra), or MenACWY-TT (MenQuadfi): IM: 0.5 mL per dose for a total of 2 doses administered at least 8 weeks apart.
At risk during an outbreak (due to vaccine serogroup) or traveling to or residing in areas where meningococcal disease is endemic/hyperendemic: MenACWY-CRM (Menveo [2-vial formulation]), MenACWY-D (Menactra), or MenACWY-TT (MenQuadfi): IM: 0.5 mL as a single dose.
Children ≥10 years and Adolescents (not previously vaccinated): Note: Administer MenACWY-D (Menactra) before or concomitantly with DTaP and ≥4 weeks after completion of all PCV doses; may be given at any time in relation to Tdap or Td.
Persistent complement deficiencies (including complement inhibitor use [eg, eculizumab, ravulizumab]); functional or anatomic asplenia; HIV infection: MenACWY-CRM (Menveo [1- or 2-vial formulation]), MenACWY-D (Menactra), or MenACWY-TT (MenQuadfi): IM: 0.5 mL per dose for a total of 2 doses administered at least 8 weeks apart.
At risk during an outbreak (due to vaccine serogroup); traveling to or residing in areas where meningococcal disease is endemic/hyperendemic; military recruits; first-year college students living in residential halls; or microbiologists routinely exposed to N. meningitidis: MenACWY-CRM (Menveo [1- or 2-vial formulation]), MenACWY-D (Menactra), or MenACWY-TT (MenQuadfi): IM: 0.5 mL as a single dose. Note: College students living in residence halls should have documentation of a vaccination not more than 5 years before entry (preferably a dose on or after their 16th birthday).
Booster vaccination (Ref):
Patients NOT at increased risk for meningococcal disease:
Adolescents ≥16 years: MenACWY-CRM (Menveo [1- or 2-vial formulation]), MenACWY-D (Menactra), or MenACWY-TT (MenQuadfi): IM: 0.5 mL as a single dose. If primary vaccination was at 11 to 12 years, the booster dose should be given at age 16. If the primary vaccination was given at 13 to 15 years, the booster dose should be given at age 16 to 18. Minimum interval between MenACWY doses is 8 weeks. A booster dose is not needed if the primary dose was given after the 16th birthday unless the person becomes at increased risk for meningococcal disease.
Patients remaining at increased risk for meningococcal disease due to complement component deficiency (including due to complement inhibitor use), anatomic or functional asplenia (including sickle cell disease), HIV infection, travel to or residence in an area where meningococcal disease is hyperendemic or endemic, or during an outbreak:
Children 3 to <10 years: MenACWY-CRM (Menveo [2-vial formulation]), MenACWY-D (Menactra), or MenACWY-TT (MenQuadfi): IM: 0.5 mL per dose; Note: Age for booster dose(s), number of dose(s), and dosing interval depends on age at previous dose and duration of increased risk.
If first dose received at <7 years of age: IM: 0.5 mL per dose; administer booster dose 3 years after primary vaccination and every 5 years thereafter if the person remains at increased risk.
If first dose received at ≥7 years of age: IM: 0.5 mL per dose; administer booster dose 5 years after primary vaccination and every 5 years thereafter if the person remains at increased risk.
Children ≥10 years and Adolescents: MenACWY-CRM (Menveo [1- or 2-vial formulation]), MenACWY-D (Menactra), or MenACWY-TT (MenQuadfi): IM: 0.5 mL per dose; Note: Age for booster dose(s), number of dose(s), and dosing interval depends on age at previous dose and duration of increased risk.
If first dose received at <7 years of age: IM: 0.5 mL per dose; administer booster dose 3 years after primary vaccination and every 5 years thereafter if the person remains at increased risk.
If first dose received at ≥7 years of age: IM: 0.5 mL per dose; administer booster dose 5 years after primary vaccination and every 5 years thereafter if the person remains at increased risk.
Canadian labeling:
Meningococcal disease, prevention:
NACI recommendations (Ref): Note: In patients ≥2 years of age, any of the available MenACWY vaccines may be used. NACI recommendations do not yet reflect the approval of Nimenrix in patients 6 weeks to 23 months of age or MenQuadfi in patients ≥12 months of age. Abbreviations identifying types of vaccine or specific products reflect NACI terminology.
Primary vaccination:
Patients NOT at increased risk for meningococcal disease:
Children ≥12 years and Adolescents: Men-C-ACWY-CRM (Menveo), Men-C-ACWY-DT (Menactra), or Men-C-ACWY-TT (Nimenrix): IM: 0.5 mL as a single dose. Note: Routinely administered at 12 years of age, regardless if previously immunized as an infant or toddler. Administer either monovalent conjugate meningococcal vaccine (Men-C-C) or quadrivalent conjugate meningococcal vaccine (Men-C-ACWY); refer to provincial/local schedules.
Patients at increased risk for meningococcal disease (due to underlying medical conditions or exposure risk) who have not been previously vaccinated:
Infants ≥2 months and Children <2 years: Dosing based on age at initial dose: MenACWY-CRM (Menveo):
≥2 to <12 months: IM: 0.5 mL per dose for 2 or 3 doses administered ≥8 weeks apart; an additional dose should be administered between 12 and 23 months of age and ≥8 weeks after the previous dose.
12 to <24 months: IM: 0.5 mL per dose for a total of 2 doses ≥8 weeks apart; doses may be administered ≥4 weeks apart if accelerated vaccination is needed.
Children ≥2 years and Adolescents: Men-C-ACWY-CRM (Menveo), Men-C-ACWY-DT (Menactra), or Men-C-ACWY-TT (Nimenrix):
Increased risk due to underlying medical conditions: IM: 0.5 mL per dose for a total of 2 doses ≥8 weeks apart; doses may be administered ≥4 weeks apart if accelerated vaccination is needed.
Increased risk due to travel: IM: 0.5 mL as a single dose.
Booster vaccination:
Patients remaining at increased risk for meningococcal disease due to underlying medical conditions or exposure risk:
Men-C-ACWY-CRM (Menveo), Men-C-ACWY-DT (Menactra), or Men-C-ACWY-TT (Nimenrix): Note: Recommendations are based on age at initial vaccination:
Initially vaccinated at <7 years of age: IM: 0.5 mL per dose every 3 to 5 years.
Initially vaccinated at ≥7 years of age: IM: 0.5 mL per dose every 5 years.
Postexposure management (close contacts) or outbreak control: Note: Recommendations dependent on meningococcal serogroup involved in exposure or outbreak; certain patients may also require chemoprophylaxis following contact with a case. Refer to provincial/local health officials for more information.
Serogroup C outbreak: Note: Monovalent meningococcal group C vaccine or quadrivalent meningococcal vaccine (MenACWY) may be used.
Children ≥11 years and Adolescents: Men-C-ACWY-CRM (Menveo), Men-C-ACWY-DT (Menactra), or Men-C-ACWY-TT (Nimenrix):
Previously unvaccinated: IM: 0.5 mL per dose; administer 1 dose immediately after exposure.
Previously vaccinated: IM: If vaccinated at <1 year of age or if at high risk for invasive meningococcal disease due to underlying medical condition, revaccinate with single dose of 0.5 mL if ≥4 weeks since last dose; otherwise revaccinate if ≥1 year since last dose.
Serogroup A, Y, or W-135 outbreak:
Infants 2 to <12 months: Men-C-ACWY-CRM (Menveo):
Previously unvaccinated or vaccinated with only meningococcal group C conjugate vaccine: IM: 0.5 mL per dose immediately after exposure then complete routine series.
Previously vaccinated with Men-C-ACWY-CRM: IM: If ≥4 weeks since last dose, revaccinate with a single 0.5 mL dose, then complete series.
Children 12 to <24 months: Men-C-ACWY-CRM (Menveo):
Previously unvaccinated or vaccinated with only meningococcal group C conjugate vaccine: IM: 0.5 mL per dose; administer 2 doses ≥8 weeks apart.
Previously vaccinated: IM: If vaccinated at <1 year of age or if at high risk for invasive meningococcal disease due to underlying medical condition, revaccinate with single dose of 0.5 mL if ≥4 weeks since last dose; otherwise revaccinate if ≥1 year since last dose.
Children ≥2 years and Adolescents: Men-C-ACWY-CRM (Menveo), Men-C-ACWY-DT (Menactra), or Men-C-ACWY-TT (Nimenrix):
Previously unvaccinated or vaccinated with only meningococcal group C conjugate vaccine: IM: 0.5 mL per dose; administer 1 dose immediately after exposure.
Previously vaccinated: IM: If vaccinated at <1 year of age or if at high risk for invasive meningococcal disease due to underlying medical condition, revaccinate with single dose of 0.5 mL if ≥4 weeks since last dose; otherwise revaccinate if ≥1 year since last dose.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Actual percentages may vary by product and age group. Adverse reactions occur with children, adolescents, and adults unless otherwise specified.
>10%:
Gastrointestinal: Anorexia (8% to 12%; infants: 30%), change in appetite (infants and children: 9% to 23%), diarrhea (infants, children, adolescents, and adults: 7% to 16%; severe diarrhea [infants: ≤2%]), nausea (5% to 12%), vomiting (2% to 3%; infants: 5% to 14%, severe vomiting: <1%)
Local: Erythema at injection site (infants, children, adolescents, and adults: 4% to 32%), induration at injection site (infants, children, adolescents, and adults: 7% to 19%), pain at injection site (17% to 59%), swelling at injection site (infants, children, adolescents, and adults: 3% to 22%), tenderness at injection site (infants and children: 10% to 41%)
Nervous system: Drowsiness (infants and children: 11% to 50%), excessive crying (infants and children: 12% to 41%), fatigue (adolescents and adults: 17% to 38%), headache (children: 5% to 18%; adolescents and adults: 19% to 41%), irritability (infants and children: 12% to 57%), malaise (10% to 28%), pain (60%)
Neuromuscular & skeletal: Arthralgia (3% to 20%), myalgia (10% to 43%)
Miscellaneous: Fever (infants, children, adolescents, and adults: ≤12%)
1% to 10%:
Dermatologic: Skin rash (infants, children, adolescents, and adults: 1% to 6%)
Nervous system: Chills (4% to 10%)
<1%:
Endocrine & metabolic: Dehydration (infants and children)
Gastrointestinal: Abdominal pain (children)
Hepatic: Viral hepatitis
Hypersensitivity: Angioedema
Infection: Herpes zoster infection, staphylococcal infection (children)
Nervous system: Dizziness, febrile seizure (children), simple focal seizures
Neuromuscular & skeletal: Herniated disc
Respiratory: Pneumonia (infants and children; lobar pneumonia [children])
Frequency not defined
Nervous system: Acute disseminated encephalomyelitis, seizure
Respiratory: Wheezing (infants)
Postmarketing:
Cardiovascular: Hypotension, syncope, vasodepressor syncope
Dermatologic: Erythema of skin, exfoliation of skin, pruritus, urticaria
Hematologic & oncologic: Lymphadenopathy
Hepatic: Increased serum alanine aminotransferase
Hypersensitivity: Anaphylaxis, hypersensitivity reaction
Local: Cellulitis at injection site, inflammation at injection site, injection-site pruritus, swelling of injected limb
Nervous system: Balance impairment, Bell palsy, facial nerve paralysis, Guillain-Barré syndrome, paresthesia, transverse myelitis, vertigo
Neuromuscular & skeletal: Ostealgia
Ophthalmic: Blepharoptosis
Otic: Auditory impairment, otalgia, vestibular disturbance
Respiratory: Apnea (premature infants), dyspnea, oropharyngeal pain, upper airway swelling
Miscellaneous: Swelling
Severe hypersensitivity (eg, anaphylaxis) to other meningococcal-containing vaccines or any component of the formulation including diphtheria toxoid or CRM197 (a diphtheria toxin carrier protein) (Menactra and Menveo only) or tetanus toxoid (MenQuadfi only).
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2022]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2022]).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2022]).
• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2022]).
• Diphtheria or tetanus immunization: Immunization with Menveo or Menactra does not substitute for routine diphtheria immunization; immunization with MenQuadfi or Nimenrix (Canadian product) does not substitute for routine tetanus immunization.
• Guillain-Barré syndrome: Has been temporally associated with Menactra; use with caution in patients with a history of Guillain-Barré syndrome.
• Meningococcal infections: Not to be used to treat meningococcal infections or to provide immunity against N. meningitidis serogroup B.
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2022]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2022]).
Administration of Menactra (MenACWY-D) 1 month after Daptacel (DTaP) has been shown to have reduced meningococcal antibody responses in children; these vaccines should be administered simultaneously or Menactra should be administered prior to or 6 months after Daptacel. If child is traveling to a hyperendemic or epidemic area or where an outbreak is occurring, administer MenACWY-D regardless of the timing of DTaP receipt. This interaction does not apply to Menveo (MenACWY-CRM) or MenQuadfi (MenACWY-TT) (CDC/ACIP [Mbaeyi 2020]).
Simultaneous administration of Menactra (MenACWY-D) and pneumococcal conjugate vaccine (7-valent) (PCV7) produced reduced concentrations of 3 serotypes of pneumococcus. Therefore, ACIP recommends that in persons with anatomic or functional asplenia or HIV, Menactra should be given ≥4 weeks after completion of the PCV13 series (ACIP [Kroger 2022]).
Special populations:
• Altered immunocompetence: Patients with certain complement deficiencies, HIV infection, or with anatomic or functional asplenia, and patients receiving complement inhibitors (eg, eculizumab, ravulizumab) are at an increased risk for invasive meningococcal infection, including post vaccination (CDC/ACIP [Mbaeyi 2020]). Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2022]; IDSA [Rubin 2014]).
• Pediatric: Apnea has been reported following IM vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (AAP [Saari 2003]; ACIP [Kroger 2022]). Children with functional or anatomic asplenia or HIV infection should delay receiving Menactra (MenACWY-D) until 2 years of age to avoid immune interference with the 13-valent pneumococcal conjugate vaccine (PCV13); Menactra should be given at least 4 weeks after completion of the PCV13 series; if meningococcal immunity is required in pediatric patients 2 to 23 months of age, the alternative is administration of Menveo (MenACWY-CRM) (CDC/ACIP [Mbaeyi 2020]).
Dosage form specific issues:
• Menveo: Menveo is available as a 1-vial formulation that does not require mixing, as well as a 2-vial formulation that requires mixing prior to administration.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2022]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions are available from the IDSA (Rubin 2014).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2022]).
Menveo is supplied in two presentations. The one vial presentation (pink cap) does not require reconstitution. The two vial presentation includes one vial containing MenA powder (orange cap) and one vial containing MenCYW-135 liquid (gray cap), for reconstitution before use.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution:
Menactra: 4 mcg each of meningococcal polysaccharides A, C, Y, and W-135 [bound to diphtheria toxoid 48 mcg] per 0.5 mL [MCV4 or MenACWY-D] [contains formaldehyde]
Injection, solution, reconstituted [preservative free]:
Menveo: MenA oligosaccharide 10 mcg, MenC oligosaccharide 5 mcg, MenY oligosaccharide 5 mcg, and MenW-135 oligosaccharide 5 mcg [bound to CRM197 protein 25.4-65.5 mcg] per 0.5 mL [MenACWY-CRM] (1 vial presentation); MenA oligosaccharide 10 mcg, MenC oligosaccharide 5 mcg, MenY oligosaccharide 5 mcg, and MenW-135 oligosaccharide 5 mcg [bound to CRM197 protein 32.7-64.1 mcg] per 0.5 mL [MenACWY-CRM] (2 vial presentation)
MenQuadfi: 10 mcg each of meningococcal polysaccharides A, C, Y, and W per 0.5 mL [may contain formaldehyde]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free]:
Menactra: 4 mcg each of meningococcal polysaccharides A, C, Y, and W-135 [bound to diphtheria toxoid ~48 mcg] per 0.5 mL
Injection, solution, reconstituted [preservative free]:
Menveo: MenA oligosaccharide 10 mcg, MenC oligosaccharide 5 mcg, MenW-135 oligosaccharide 5 mcg, and MenY oligosaccharide 5 mcg [bound to CRM197 protein ~47 mcg] per 0.5 mL [MenACWY-CRM; supplied in two vials, one containing MenA powder and one containing MenCYW-135 liquid]
Nimenrix: 5 mcg each of meningococcal polysaccharides A, C, Y, and W-135 [bound to tetanus toxoid 44 mcg] per 0.5 mL
IM: Administer by IM route, preferably into the central deltoid region. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not administer via IV, SUBQ, or intradermal route. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
For patients at risk of hemorrhage, the vaccine should be administered intramuscularly if, in the opinion of a physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient or family should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
For IM administration only. Based on limited data, inadvertent SUBQ administration provides a lower serologic response; however, the response is still considered to be protective. If inadvertently administered by the SUBQ route, revaccination is not necessary.
Menveo: Prior to using the 2-vial formulation, the powder (MenA vial) must be reconstituted with the liquid (MenCYW vial). If the liquid MenCYW is advertently administered without the MenA component, then revaccination is not needed unless the patient plans to travel internationally (ie, region where serogroup A meningococcal disease is endemic or where vaccination is required) (Ref).
IM: Administer by IM injection into anterolateral aspect of the thigh in infants and in the deltoid muscle to children and adolescents. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Not for intradermal, SUBQ, or IV administration. Menveo (2-vial formulation) and Nimenrix [Canadian product] must be administered within 8 hours after reconstitution. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (Ref). To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
Menveo (2-vial formulation): Must be reconstituted prior to use to ensure all serotypes of quadrivalent vaccine in dose for administration (see "Preparation for Administration"; 1-vial formulation does not require reconstitution). If the liquid MenCYW is accidentally administered without the MenA component, then revaccination is not needed unless the patient plans to travel internationally to a region where serogroup A meningococcal disease is endemic or where vaccination is required (Ref).
For patients at risk of hemorrhage, the vaccine should be administered IM if, in the opinion of a physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient or family should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
Based on limited data, inadvertent SUBQ administration provides a lower serologic response; however, the response is still considered to be protective. If inadvertently administered by the SUBQ route, revaccination is not necessary.
In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/mening.html.
Meningococcal disease prevention: Active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in the following persons:
- Menveo: ≥2 months to ≤55 years of age (2-vial formulation); ≥10 years to ≤55 years of age (1-vial formulation)
- Menactra: ≥9 months to ≤55 years of age
- MenQuadfi: ≥2 years of age (US labeling); ≥12 months of age (Canadian labeling)
- Nimenrix (Canadian product): ≥6 weeks to ≤55 years of age
The Advisory Committee on Immunization Practices (ACIP) (CDC/ACIP [Mbaeyi 2020]):
ACIP recommends routine vaccination of the following:
- Children and adolescents 11 or 12 years of age with a booster dose at 16 years of age.
- Persons ≥2 months of age who are at increased risk of meningococcal disease.
- Persons ≥2 months of age at increased risk during an outbreak (eg, in community or organizational settings, and among men who have sex with men).
Those at increased risk of meningococcal disease include the following:
- Persons with certain medical conditions such as anatomic or functional asplenia (including sickle cell disease), HIV infection, or complement component deficiencies (eg, C3, C5-C9, properdin, factor H, or factor D deficiencies; persons receiving complement inhibitors [eg, eculizumab, ravulizumab]).
- Persons who travel to or reside in countries where meningococcal disease is hyperendemic or epidemic.
- Unvaccinated or incompletely vaccinated first year college students living in residence halls.
- Military recruits.
- Microbiologists with routine exposure to Neisseria meningitidis isolates.
The Canadian National Advisory Committee on Immunization (NACI): NACI recommends a routine vaccination at ~12 years of age but no booster unless at a continued high risk of exposure. Any quadrivalent vaccine may be used; NACI does not have a preference. NACI recommends use of Menveo (off-label use) for high risk persons 2 months to 2 years of age if vaccination with a quadrivalent vaccine is needed; may also be considered for use in persons ≥56 years of age (NACI 39[1] 2013). Additional recommendations may be found at https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-13-meningococcal-vaccine.html.
MenACWY-D (Menactra) may be confused with MenACWY-CRM (Menveo) or MenACWY-TT (MenQuadfi).
MCV (meningococcal conjugate vaccine; MCV4 is the correct abbreviation) may be confused with PCV (pneumococcal conjugate vaccine; PCV13 is the correct abbreviation).
MCV (meningococcal conjugate vaccine; MCV4 is the correct abbreviation) may be confused with MMR (measles, mumps, and rubella virus vaccine).
MCV4 may be confused with MMRV (measles, mumps, rubella, and varicella) vaccine.
Meningococcal ACWY (MenACWY) vaccine may be confused with meningococcal B (MenB) vaccine.
Menactra (MenACWY-D) and MenQuadfi (MenACWY-TT) should be administered by intramuscular (IM) injection only. Inadvertent subcutaneous (SUBQ) administration of Menactra has been reported; possibly due to confusion of this product with Menomune (MPSV4), a meningococcal polysaccharide vaccine, which is administered by the SUBQ route. MPSV4 is no longer available in the United States.
Menveo (MenACWY-CRM) is supplied as a 1-vial formulation and also as a 2-vial formulation, one containing MenCYW-135 liquid and one containing MenA lyophilized powder, which must be mixed together in order to administer the recommended vaccine components. Errors have occurred when both vials were not used or were mixed improperly. Ensure proper preparation before administering.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine: May diminish the therapeutic effect of Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine. More specifically, prior administration of the diphtheria and tetanus toxoids, and acellular pertussis vaccine may diminish antibody response to the meningococcal (groups A / C / Y / and W-135) diphtheria conjugate vaccine in some patients. Management: Administer the meningococcal (groups A / C / Y and W-135) conjugate vaccine (Menactra brand) before or concurrently with the diphtheria and tetanus toxoids, and acellular pertussis vaccine (Daptacel brand) in children 4 to 6 years of age. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Pneumococcal Conjugate Vaccine (13-Valent): Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine may diminish the therapeutic effect of Pneumococcal Conjugate Vaccine (13-Valent). Management: Administer MenACYW-D (Menactra brand) vaccine at least 4 weeks after the final dose of the PCV13 vaccine series in patients with anatomic asplenia or functional asplenia. For details and recommendations for children under 2 years, see full monograph. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
Tetanus Toxoids Vaccines: May diminish the therapeutic effect of Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine. Management: When possible, administer the meningococcal polysaccharide (groups A / C / Y and W-135) conjugate vaccine (Nimenrix brand) either together with, or at least one month before, a tetanus toxoids-containing vaccine. Risk D: Consider therapy modification
Based on available data, an increased risk of adverse pregnancy outcomes has not been observed following maternal vaccination with a meningococcal (Groups A / C / Y and W-135) diphtheria conjugate vaccine (Becerra-Culqui 2020; CDC/ACIP [Mbaeyi 2020]; Myers 2017; Zheteyeva 2013).
Inactivated bacterial vaccines have not been shown to cause increased risks to the fetus. Use of meningococcal conjugate vaccines may be considered for use in pregnant patients at increased risk of infection (ACIP [Kroger 2022]). Pregnant patients should be vaccinated if otherwise indicated (CDC/ACIP [Mbaeyi 2020]).
Data collection to monitor pregnancy and infant outcomes following exposure to Menactra or MenQuadfi is ongoing. Health care providers are encouraged to enroll patients exposed to Menactra or MedQuadfi during pregnancy in the Sanofi Pasteur Inc vaccine registry (1-800-822-2463).
It is not known if this vaccine is present in breast milk.
According to the manufacturer, the decision to continue or discontinue breastfeeding following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of vaccination to the mother. Inactivated vaccines do not affect the safety of breastfeeding for the mother or the infant (ACIP [Kroger 2022]). Lactating patients should be vaccinated if otherwise indicated (CDC/ACIP [Mbaeyi 2020]). Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2022]).
Monitor for hypersensitivity and syncope for at least 15 minutes following administration (ACIP [Kroger 2022]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Induces immunity against meningococcal disease via the formation of bactericidal antibodies directed toward the polysaccharide capsular components of Neisseria meningitidis serogroups A, C, Y and W-135.
Onset of action: Postvaccination seroconversion is typically achieved by 1 month following dose (or last dose in a series, if multiple doses given). (CDC/ACIP [Mbaeyi 2020]).
Duration of action: Antibody waning is observed over 3 to 5 years following primary vaccination; in adolescents, antibodies persist for ≥4 years following a booster dose. Antibody waning may vary with specific product and among serogroups (CDC/ACIP [Mbaeyi 2020]).
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