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Meningococcal (Groups A / C / Y and W-135) Diphtheria Conjugate Vaccine

Medically reviewed by Drugs.com. Last updated on June 14, 2020.

Pronunciation

(me NIN joe kok al groops aye, see, why & dubl yoo won thur tee fyve KON joo gate vak SEEN)

Index Terms

  • MCV
  • MCV4
  • MenACWY
  • MenACWY-CRM (Menveo)
  • MenACWY-CRM197 (Menveo)
  • MenACWY-D (Menactra)
  • MenACWY-TT (MenQuadfi)
  • Meningococcal Conjugate Vaccine
  • MenQuadfi
  • Nimenrix

Dosage Forms

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 32.7-64.1 mcg] per 0.5 mL [MenACWY-CRM; supplied in two vials, one containing MenA powder and one containing MenCYW-135 liquid]

MenQuadfi: 10 mcg each of meningococcal polysaccharides A, C, Y, and W per 0.5 mL [may contain formalehyde]

Brand Names: U.S.

  • Menactra
  • MenQuadfi
  • Menveo

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)

Pharmacology

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.

Use: Labeled Indications

Meningococcal disease prevention: Active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in the following persons:

- ≥2 months to ≤ 55 years of age (Menveo)

- ≥9 months to ≤ 55 years of age (Menactra)

- ≥2 years of age (MenQuadfi)

- ≥6 weeks to ≤ 55 years of age (Nimenrix) [Canadian product]

The Advisory Committee on Immunization Practices (ACIP) (CDC/ACIP [Cohn 2013]; CDC/ACIP [MacNeil 2014]; CDC/ACIP [MacNeil 2016]):

ACIP recommends routine vaccination of the following:

- Children and adolescents 11 to 18 years of age

- Persons ≥2 months of age who are at increased risk of meningococcal disease

- Persons (in all recommended age groups) at increased risk who are part of outbreaks caused by vaccine preventable serogroups

Those at increased risk of meningococcal disease include the following:

- Persons ≥2 months of age with medical conditions such as anatomic or functional asplenia (including sickle cell disease), HIV, or persistent complement component deficiencies (eg, C5-C9, properdin, factor H, or factor D, persons receiving complement inhibitors [eg, eculizumab, ravulizumab])

- Persons ≥2 months of age who travel to or reside in countries where meningococcal disease is hyperendemic or epidemic, especially if contact with the local population will be prolonged

- Unvaccinated or incompletely vaccinated first year college students living in residence halls (CDC/ACIP [Bilukha 2005])

- Military recruits

- Microbiologists with occupational exposure

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. Either 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.

Contraindications

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).

Dosing: Adult

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should NOT be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, outpatient visits solely for vaccination should be delayed in persons in quarantine due to close contact with COVID-19 or persons who have suspected or confirmed COVID-19 infection (regardless of symptoms); refer to the CDC's "Interim Guidance for Immunization Services During the COVID-19 Pandemic" for current recommendations (https://www.cdc.gov/vaccines/pandemic-guidance/index.html). Additional information is available from the American Academy of Pediatrics and the Immunization Action Coalition.

Meningococcal disease, prevention:

ACIP recommendations (CDC/ACIP [Bilukha 2005]; CDC/ACIP [Cohn 2013]; CDC/ACIP [MacNeil 2016]): 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. Note: CDC/ACIP recommendations do not currently discuss MenQuadfi.

Primary vaccination:

Adults 19 to 21 years: 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.

Primary vaccination: Persons at increased risk for meningococcal disease:

Note: If using MenACWY-D (Menactra), administer ≥4 weeks after completion of all pneumococcal conjugate vaccine doses.

Adults not previously vaccinated and who have persistent complement deficiencies (including complement inhibitor use [eg, eculizumab, ravulizumab]), functional or anatomic asplenia, or who have HIV infection: MenACWY-CRM (Menveo) or MenACWY-D (Menactra): IM: Two 0.5 mL doses, given ≥2 months apart.

Other adults not previously vaccinated and 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: MenACWY-CRM (Menveo) or MenACWY-D (Menactra): 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).

Booster dose: Persons NOT at increased risk for meningococcal disease (routine immunization): Adults ≤21 years of age: MenACWY-CRM (Menveo) or MenACWY-D (Menactra): 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.

Booster vaccination: Persons at increased risk for meningococcal disease: Repeat dose every 5 years if the person remains at increased risk.

NACI recommendations (NACI 2020):

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; military recruits; laboratory personnel routinely exposed to N. meningitidis): IM: Two 0.5 mL doses, given 8 weeks apart. Note: Doses may be administered ≥4 weeks apart if accelerated vaccination is needed.

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) (NACI 2020): 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.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should NOT be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, outpatient visits solely for vaccination should be delayed in persons in quarantine due to close contact with COVID-19 or persons who have suspected or confirmed COVID-19 infection (regardless of symptoms); refer to the CDC's "Interim Guidance for Immunization Services During the COVID-19 Pandemic" for current recommendations (https://www.cdc.gov/vaccines/pandemic-guidance/index.html). Additional information is available from the American Academy of Pediatrics and the Immunization Action Coalition.

Note: Use of the abbreviation, MenACWY, refers to either meningococcal quadrivalent conjugate vaccine. MenACWY-CRM refers specifically to Menveo; MenACWY-D refers specifically to Menactra. 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 (ACIP [Ezeanolue 2020]).

Primary immunization:

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 (CDC/ACIP [Cohn 2013]; CDC/ACIP [MacNeil 2014]; CDC/ACIP [MacNeil 2016]).

CDC (ACIP) recommendations (ACIP [Robinson 2018]; CDC/ACIP [Cohn 2013]; CDC/ACIP [MacNeil 2014]; CDC/ACIP [MacNeil 2016]):

Primary vaccination for patients NOT at increased risk for meningococcal disease:

Infants and Children <11 years: Not routinely recommended; see dosing for persons at increased risk.

Children 11 to 12 years: MenACWY-CRM (Menveo) or MenACWY-D (Menactra): IM: 0.5 mL as a single dose. Children not at increased risk for meningococcal disease who may have been previously vaccinated with Hib-MenCY-TT (Menhibrix) or MenACWY (Menactra or Menveo) prior to their 10th birthday should receive the routinely recommended dose of MenACWY at 11 to 12 years.

Adolescents: IM: 0.5 mL as a single dose if not previously vaccinated.

Primary vaccination for patients at increased risk for meningococcal disease: Note: If MenACWY-D (Menactra) product is used, administer it before or concomitantly with DTaP, and administer ≥4 weeks after completion of all PCV doses as age appropriate.

Infants ≥2 months and Children <2 years:

Anatomic or functional asplenia (including sickle cell disease): Dosing based on age at initial dose:

Infants 8 weeks to 6 months: MenACWY-CRM (Menveo): IM: 0.5 mL per dose for a total of 4 doses administered at 2, 4, 6, and 12 months of age.

Children 7 to 23 months (incomplete vaccination): MenACWY-CRM (Menveo): IM: 0.5 mL per dose for a total of 2 doses administered at least 12 weeks apart; the second dose should be administered at least 12 weeks after the first dose.

Persistent complement component deficiency (including complement inhibitor use [eg, eculizumab, ravulizumab) or HIV-exposed/-infected: Dosing based on age at first dose:

Infants 8 weeks to 6 months: MenACWY-CRM (Menveo): IM: 0.5 mL per dose for a total of 4 doses administered at 2, 4, 6, and 12 months of age.

Infants and Children 7 to 23 months:

MenACWY-CRM (Menveo): Infants and Children 7 to 23 months: IM: 0.5 mL per dose for a total of 2 doses; the second dose should be given 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 given 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 administer ≥4 weeks after completion of all PCV doses.

Community outbreak (due to vaccine serogroup): Infants ≥2 months to Children 23 months: Initiate or complete an age appropriate series of MenACWY-CRM (Menveo) or MenACWY-D (Menactra); see previous Primary immunization for dosing.

Travel to or residence in countries with hyperendemic or epidemic meningococcal disease: Infants 2 months to Children 23 months: Initiate or complete an age appropriate series of MenACWY-CRM (Menveo) or MenACWY-D (Menactra); see previous Primary immunization for dosing.

Children ≥2 years and Adolescents, not previously vaccinated and who have persistent complement deficiencies (including complement inhibitor use [eg, eculizumab, ravulizumab]), functional or anatomic asplenia, or who have HIV infection: MenACWY-CRM (Menveo) or MenACWY-D (Menactra): IM: 0.5 mL per dose for a total of 2 doses administered at least 8 weeks apart.

Other Children ≥2 years and Adolescents at increased risk not previously vaccinated and who are either: First year college students ≤21 years of age living in residential housing, traveling to or residents of areas where meningococcal disease is endemic/hyperendemic, at risk during a community outbreak, or microbiologists routinely exposed to N. meningitidis: MenACWY-CRM (Menveo) or MenACWY-D (Menactra): IM: 0.5 mL as a single dose. College students ≤21 years should have documentation of a vaccination not more than 5 years before enrollment (preferably a dose on their 16th birthday).

Booster dose: (CDC/ACIP [Cohn 2013]):

Booster vaccination for patients NOT at increased risk for meningococcal disease: 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 (Menveo or Menactra) 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.

Booster vaccination for patients at increased risk for meningococcal disease:

If first dose received at 2 months to 6 years of age: Repeat 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: Repeat dose 5 years after primary vaccination and every 5 years thereafter if the person remains at increased risk.

Reconstitution

Menveo: Prior to use, remove entire contents from vial of MenCYW-135 and inject into vial containing MenA powder. Invert and shake well until dissolved. The resulting solution should be clear, colorless, and particle free. A small amount of liquid will remain in the vial after withdrawing the 0.5 mL dose.

Nimenrix [Canadian product]: Add entire contents of prefilled syringe containing diluent to the vial containing powder. Shake the vial until the powder completely dissolves. Resulting solution should be clear and colorless. Withdraw solution from vial using new needle.

Administration

IM: Administer by IM route, preferably into the central deltoid region. 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 (ACIP [Ezeanolue 2020]). 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 (ACIP [Ezeanolue 2020]).

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.

Storage

Menactra, MenQuadfi: Store between 2°C to 8°C (35°F to 46°F); do not freeze. Discard product exposed to freezing.

Menveo: Prior to reconstitution, store between 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Use immediately after reconstitution but may be stored at 2°C to 25°C (36°F to 77°F) for up to 8 hours; do not freeze. Discard product exposed to freezing.

Nimenrix [Canadian product]: Prior to reconstitution, store between 2°C to 8°C (36°F to 46°F). Prefilled syringe containing diluent may be stored at 25°C (77°F). Do not freeze. Protect from light. After reconstitution, the vaccine is stable for 8 hours at 30°C (86°F); however, administration immediately following reconstitution is recommended. Discard vaccine if not used within 8 hours.

Drug Interactions

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. Consider therapy modification

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). 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. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated less than 2 weeks before starting or during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. 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: It is recommended to administer PCV13 at least 4 weeks prior to the administration of MenACYW-D (Menactra brand) vaccine in persons with anatomic asplenia or functional asplenia. This interaction does not apply to other brands of meningococcal vaccine. Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. 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. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

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 (26% 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: Simple partial seizures

Neuromuscular & skeletal: Herniated disc

Respiratory: Pneumonia (infants and children; lobar pneumonia [children])

Miscellaneous: Febrile seizure (children)

Frequency not defined

Nervous system: Acute disseminated encephalomyelitis, seizure

Respiratory: Wheezing (infants)

Postmarketing:

Cardiovascular: Hypotension, swelling of injected limb, syncope, vasodepressor syncope

Dermatologic: Erythema of skin, exfoliation of skin, injection site pruritus, pruritus, urticaria

Hematologic & oncologic: Lymphadenopathy

Hepatic: Increased serum alanine aminotransferase

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Local: Cellulitis at injection site, inflammation at injection site

Nervous system: Balance impairment, Bell’s palsy, dizziness, 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

Warnings/Precautions

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 [Ezeanolue 2020]).

• 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 [Ezeanolue 2020]).

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 [Ezeanolue 2020]).

• 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 [Ezeanolue 2020]).

• 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 or diphtheria.

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Ezeanolue 2020]).

• 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 [Ezeanolue 2020]).

Administration of Menactra (MenACWY-D) one month after Daptacel (DTaP) has been shown to have reduced meningococcal antibody responses in children; for children ages 2 through 6 years, these vaccines should be administered simultaneously or Menactra should be administered prior to or 6 months after Daptacel. This interaction does not apply to Menveo (MenACWY-CRM) (CDC/ACIP [Cohn 2013]).

Special populations:

• Altered immunocompetence: Patients with certain complement deficiencies and patients receiving treatment that inhibits terminal complement activation (eg, eculizumab, ravulizumab) are at an increased risk for invasive meningococcal infection, including post-vaccination. 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 [Ezeanolue 2020]; 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 [Ezeanolue 2020]). Children with functional or anatomic asplenia 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 [MacNeil 2014]).

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 [Ezeanolue 2020]). 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 [Ezeanolue 2020]).

• Tetanus vaccine: MenQuadfi and Nimenrix (Canadian product) are not a substitute for routine tetanus immunization.

Monitoring Parameters

Monitor for hypersensitivity and syncope for at least 15 minutes following administration (ACIP [Ezeanolue 2020]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Considerations

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; 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 women at increased risk of infection (ACIP [Ezeanolue 2020]). Pregnancy should not preclude vaccination if otherwise indicated (CDC/ACIP [Cohn 2013]).

Data collection to monitor pregnancy and infant outcomes following exposure to Menactra or MenQuadfi is ongoing. Health care providers are encouraged to enroll females exposed to Menactra or MedQuadfi during pregnancy in the Sanofi Pasteur Inc vaccine registry (1-800-822-2463).

Patient Education

What is this drug used for?

• It is used to prevent meningococcal disease.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Injection site pain, swelling, or irritation

• Headache

• Loss of strength and energy

• Muscle pain

• Joint pain

• Lack of appetite

• Diarrhea

• Irritability (children)

• Fatigue (children)

• Abnormal crying (children)

• Chills (children)

• Vomiting (children)

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe dizziness

• Passing out

• Abnormal movements

• Facial paralysis

• Muscle weakness

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.