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

Pronunciation

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

Index Terms

  • MCV
  • MCV4
  • MenACWY
  • MenACWY-CRM (Menveo)
  • MenACWY-D (Menactra)
  • Meningococcal Conjugate Vaccine

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution [preservative free]:

Menactra: 4 mcg each of polysaccharide antigen groups A, C, Y, and W-135 [bound to diphtheria toxoid 48 mcg] per 0.5 mL [MCV4 or MenACWY-D]

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 (0.5 mL) [MenACWY-CRM; supplied in two vials, one containing MenA powder and one containing MenCYW-135 liquid]

Brand Names: U.S.

  • Menactra
  • 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: Provide active immunization of children and adults against invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W-135.

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

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) or persistent compliment component deficiencies (eg, C5-C9, properdin, factor H, or factor D)

- Persons ≥2 months of age that 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

- 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 www.phac-aspc.gc.ca/publicat/ccdr-rmtc/13vol39/acs-dcc-1/index-eng.php

Contraindications

Hypersensitivity to other meningococcal-containing vaccines or any component of the formulation including diphtheria toxoid or CRM197 (a diphtheria toxin carrier protein)

Dosing: Adult

Immunization: IM:

Manufacturer’s labeling: Menactra, Menveo: Adults ≤55 years: 0.5 mL/dose given as single dose

ACIP recommendations (ACIP [Kim 2016]; CDC/ACIP [Cohn 2013]) Use of the abbreviation, MenACWY, refers to either meningococcal quadrivalent conjugate vaccine. MenACWY-CRM refers specifically to Menveo; MenACWY-D refers specifically to Menactra.

Primary vaccination:

Adults 19 to 21 years: Not routinely recommended; may receive one 0.5 mL dose as a catch-up vaccination if no dose was received after the sixteenth birthday. Note: Patients who are HIV positive should receive 2 doses 2 months apart.

Adults ≥22 years: Not routinely recommended; see dosing for persons at increased risk

Primary vaccination: Persons at increased risk for meningococcal disease:

Adults ≤55 years not previously vaccinated and who have persistent complement deficiencies, functional or anatomic asplenia, or who have HIV infection plus another indication for vaccination: Two 0.5 mL doses, given ≥2 months apart. If using MenACWY-D (Menactra), administer ≥4 weeks after completion of all PCV doses

Adults ≤55 years 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, military recruits, or microbiologists routinely exposed to Neisseria meningitidis: One 0.5 mL dose. If using MenACWY-D (Menactra), administer ≥4 weeks after completion of all PCV doses. College students ≤21 years should have documentation of a vaccination not more than 5 years before enrollment (preferably a dose on their sixteenth birthday). Note: Patients who are HIV positive should receive 2 doses 2 months apart.

Adults ≥56 years: Meningococcal polysaccharide vaccine (MPSV4, Menomune) is preferred for meningococcal vaccine-naïve persons in this age group who require a single dose. If multiple doses are anticipated, see booster dosing for persons at increased risk.

Booster dose: Persons NOT at increased risk for meningococcal disease: Adults ≤21 years: 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:

Manufacturer labeling: Menactra: Repeat a single dose ≥4 years after prior dose.

ACIP recommendations (ACIP [Kim 2016]; CDC/ACIP [Cohn 2013]):

Adults ≤55 years: Repeat dose every 5 years if the person remains at increased risk.

Adults ≥56 years: Persons previously vaccinated with MenACWY and who require revaccination or for whom multiple doses are anticipated, MenACWY (Menactra or Menveo) is preferred. Otherwise, meningococcal polysaccharide vaccine (MPSV4, Menomune) is preferred for meningococcal vaccine naïve persons in this age group who require a single dose.

Dosing: Pediatric

Immunization: IM:

Manufacturer’s labeling:

Menactra:

Infants ≥9 months and Children <2 years: 0.5 mL/dose given as a 2-dose series, 3 months apart

Children ≥2 years and Adolescents: Refer to adult dosing.

Menveo: Age at initial vaccination:

Infants 2 months to <7 months: 0.5 mL/dose given as a 4-dose series at 2, 4, 6, and 12 months of age

Infants ≥7 months and Children <2 years: 0.5 mL/dose given as a 2-dose series, with the second dose given during the second year of life and at least 3 months after the first dose

Children 2 to <6 years: 0.5 mL/dose given as a single dose; for children at continued high risk of meningococcal disease, may consider an additional dose given 2 months after the first dose

Children ≥6 years and Adolescents: Refer to adult dosing.

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

Primary vaccination:

Infants, Children, and Adolescents:

<11 years: Not routinely recommended; see dosing for persons at increased risk

11 to 12 years: One 0.5 mL dose. Children not at increased risk for meningococcal disease who may have been previously vaccinated with Hib-MenCY-TT (MenHibrix) or MenACWY prior to their tenth birthday, should receive the routinely recommended doses of MenACWY at 11 to 12 years. Note: Patients who are HIV positive should receive 2 doses 2 months apart.

13 to 18 years: One 0.5 mL dose if not previously vaccinated. Note: Patients who are HIV positive should receive 2 doses 2 months apart.

Primary vaccination: Persons at increased risk for meningococcal disease:

Infants ≥2 months and Children <2 years with anatomic or functional asplenia, including sickle-cell disease: Dosing based on age at initial dose:

Infants and Children 8 weeks to 6 months: MenACWY-CRM (Menveo): IM: 0.5 mL per dose for a total of 4 doses given as follows: 2, 4, 6, and 12 months

Children 7 to 23 months (incomplete vaccination): MenACWY-CRM (Menveo): 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.

Infants ≥2 months and Children <2 years with persistent complement component deficiency: 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 given as follows: 2, 4, 6, and 12 months

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 three months after the first dose. May be given as early as 8 weeks apart if needed prior to travel.

Infants and Children 2 months to 2 years for community outbreak (due to vaccine serogroup): Initiate or complete an age appropriate series of MenACWY-CRM (Menveo) or MenACWY-D (Menactra); see Primary vaccination above for dosing.

Infants and Children 2 months to <2 years with travel to or residence in countries with hyperendemic or epidemic meningococcal disease: Initiate or complete an age appropriate series of MenACWY-CRM (Menveo) or MenACWY-D (Menactra); see Primary vaccination above for dosing.

Children ≥2 years and Adolescents not previously vaccinated and who have persistent complement deficiencies, functional or anatomic asplenia, or who have HIV infection plus another indication for vaccination: Two 0.5 mL doses, given ≥2 months apart apart. If using MenACWY-D (Menactra), administer ≥4 weeks after completion of all PCV doses

Children ≥2 years and Adolescents 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, military recruits, or microbiologists routinely exposed to Neisseria meningitidis: One 0.5 mL dose. If using MenACWY-D (Menactra), administer ≥4 weeks after completion of all PCV doses. College students ≤21 years should have documentation of a vaccination not more than 5 years before enrollment (preferably a dose on their sixteenth birthday). Note: Patients who are HIV positive should receive 2 doses 2 months apart.

Booster dose: Persons NOT at increased risk for meningococcal disease: Children ≥11 years and Adolescents: 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 sixteenth birthday unless the person becomes at increased risk for meningococcal disease. (CDC/ACIP [Cohn 2013])

Booster vaccination: Persons at increased risk for meningococcal disease:

Manufacturer labeling: Menactra: Adolescents ≥15 years: Repeat a single dose ≥4 years after prior dose.

ACIP recommendations (CDC/ACIP [Cohn 2013]):

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.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

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 and colorless. A small amount of liquid will remain in the vial after withdrawing the 0.5 mL dose.

Administration

Administer by IM route, preferably into the anterolateral aspect of the thigh (infants) or upper deltoid region (toddlers, adolescents, and adults). Do not administer via IV, SubQ or intradermal route. To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). U.S. law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

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 (NCIRD/ACIP 2011).

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.

Compatibility

Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.

Storage

Menactra: 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. Discard product exposed to freezing. Use immediately after reconstitution but may be stored at ≤25°C (77°F) for up to 8 hours.

Drug Interactions

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. 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: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

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

Adverse Reactions

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

Actual percentages may vary by product and age group:

>10%:

Central nervous system: Drowsiness, excessive crying, fatigue, headache, irritability, malaise

Gastrointestinal: Anorexia, change in appetite, diarrhea, nausea, vomiting

Local: Erythema at injection site, induration at injection site, pain at injection site, swelling at injection site, tenderness at injection site

Neuromuscular & skeletal: Arthralgia, myalgia

Miscellaneous: Fever

1% to 10%:

Central nervous system: Chills

Dermatologic: Skin rash

<1% (Limited to important or life-threatening): Acute disseminated encephalomyelitis, anaphylactoid reaction, anaphylaxis, apnea (premature infants), appendicitis, auditory impairment, Bell’s palsy, blepharoptosis, convulsions (including tonic), Cushing’s syndrome, dehydration, depression, equilibrium disturbance, exfoliation of skin, facial paresis, falling, febrile seizures, gastroenteritis, Guillain-Barre syndrome, hypersensitivity, hypotension, increased serum ALT, inflammation at injection site, injection site cellulitis, Kawasaki Syndrome, ostealgia, pelvic inflammatory disease, pneumonia, pruritus at injection site, seizure, simple partial seizures, staphylococcal infection, suicidal tendencies, syncope (including vasovagal), transverse myelitis, varicella, vertebral disc disease, vestibular disturbance

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 (NCIRD/ACIP 2011).

• Guillain-Barré syndrome (GBS): Risk of developing GBS may be increased following vaccination in persons previously diagnosed with GBS. The risk of developing GBS was evaluated in a study of healthcare claims of persons 11-18 years of age (n= ~9,600,000; 15% were vaccinated with Menactra); 72 cases of GBS were confirmed and none received the vaccine within 42 days prior to symptoms; 129 reported cases of GBS could not be confirmed or excluded. Data not currently available to assess possible risk of GBS following use of Menveo. Individuals with a previous history of GBS should only receive Menactra after an assessment of risks and benefits.

• 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 (NCIRD/ACIP 2011).

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. Consider deferring 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).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; 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 (NCIRD/ACIP 2011).

• 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:

• 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 (NCIRD/ACIP 2011).

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (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 (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

• Premature infants: Apnea has been reported following IM vaccine administration in premature infants; consider risk versus benefit in infants born prematurely. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (NCIRD/ACIP 2011).

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). 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 ACIP Recommended Adult Immunization Schedule (ACIP [Kim 2016]). 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 (NCIRD/ACIP 2011).

Monitoring Parameters

Monitor for syncope for at least 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Risk Factor

B/C (manufacturer dependent)

Pregnancy Considerations

Animal reproduction studies have not been conducted with Menactra. Limited information is available following inadvertent use of Menactra during pregnancy (Zheteyeva 2013). Patients should contact the Sanofi Pasteur Inc vaccine registry at 1-800-822-2463 if they are pregnant or become aware they were pregnant at the time of Menactra vaccination.

Adverse events were not observed in animal reproduction studies conducted with Menveo. Limited information is available following inadvertent use of Menveo during pregnancy. Patients should contact the Novartis Vaccines and Diagnostics Inc. pregnancy registry at 1-877-311-8972 if they are pregnant or become aware they were pregnant at the time of Menveo vaccination.

Inactivated bacterial vaccines have not been shown to cause increased risks to the fetus (NCIRD/ACIP 2011). Pregnancy should not preclude vaccination if indicated (CDC/ACIP [Cohn 2013]).

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site pain or irritation, headache, loss of strength and energy, muscle pain, joint pain, lack of appetite, diarrhea, irritability (children), fatigue (children), abnormal crying (children), or vomiting (children). Have patient report immediately to prescriber severe dizziness, passing out, abnormal movements, facial paralysis, or muscle weakness (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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