Introduction

Inactivated (polysaccharide) vaccine. Commercially available in US as 3 different quadrivalent conjugated (MenACWY) vaccines: meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D; Menactra), meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine (MenACWY-CRM; Menveo), and meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT; MenQuadfi). Each contains A, C, Y, and W-135 capsular polysaccharide antigens extracted from Neisseria meningitidis linked to a carrier protein.

Uses for Meningococcal Groups A, C, Y, and W-135 Vaccine

Prevention of Meningococcal Infection

Prevention of meningococcal infection caused by N. meningitidis serogroups A, C, Y, and W-135 in adults, adolescents, children, and infants ≥2 months of age.

N. meningitidis can cause invasive meningococcal disease that usually presents as severe and potentially life-threatening meningitis and/or meningococcemia with abrupt onset; transmitted person to person by the respiratory route. In the US, N. meningitidis serogroups B, C, and Y cause most cases of meningococcal disease and serogroup W-135 causes a small percentage of cases; approximately 60% of cases in individuals ≥24 years of age are caused by serogroups C, Y, or W-135. Although overall incidence of meningococcal disease in the US has been historically low during the last 10–15 years (about 329 cases reported to CDC during 2018), overall case fatality rate has remained 10–15% (even with appropriate anti-infective treatment) and fatality rate can be higher in those with meningococcemia. In addition, long-term sequelae (e.g., hearing loss, neurologic disability, digit or limb amputations) reported in up to 20% of patients. While 95% of US cases of meningococcal disease are sporadic, localized outbreaks do occur and most outbreaks have been caused by serogroups B and C.

CDC's Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine in all adolescents, preferably at 11 through 12 years of age, followed by a booster dose at 16 years of age. Catch-up vaccination recommended at 13 through 18 years of age for those not previously vaccinated; catch-up vaccination also recommended for all first-year college students living in residence halls who did not receive a dose of MenACWY vaccine on or after their 16th birthday.

ACIP, AAP, and others also recommend routine primary and booster vaccination against meningococcal serogroups A, C, Y, and W-135 infection using age-appropriate MenACWY vaccine in selected infants, children, adolescents, and adults at increased risk because of certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, HIV infection) or because they will be traveling to or residing in areas with hyperendemic or epidemic meningococcal disease caused by serogroups represented in the vaccine. Also recommended in some other individuals at increased risk (e.g., certain laboratory personnel, military recruits).

MenACWY vaccine may be used as an adjunct to anti-infective prophylaxis in household and other close contacts of individuals with invasive meningococcal disease when clusters or outbreaks are occurring and are caused by meningococcal serogroups represented in the vaccine (i.e., A, C, Y, W-135).

MenACWY vaccine provides protection only against N. meningitidis serogroups represented in the vaccine (i.e., serogroups A, C, Y, W-135); will not prevent meningococcal infection caused by other serogroups (e.g., serogroup B) and will not prevent infections caused by other pathogens.

ACIP and AAP do not state a preference for MenACWY-D, MenACWY-CRM, or MenACWY-TT; any age-appropriate vaccine can be used for primary immunization and/or revaccination or booster doses. Consider that dosage schedules (i.e., number and timing of doses for primary immunization) differ depending on which vaccine used. (See Dosage under Dosage and Administration.)

Preexposure Vaccination Against Meningococcal Infection in High-risk Groups

Infants 2 through 23 months of age with certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, HIV infection) and those who will be traveling to or residing in areas where meningococcal infection is hyperendemic or epidemic are at increased risk for meningococcal infection and should receive routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using age-appropriate MenACWY vaccine. Routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection not recommended in infants not at increased risk.

Children 2 through 10 years of age with certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, HIV infection) and those who will be traveling to or residing in areas where meningococcal infection is hyperendemic or epidemic are at increased risk for meningococcal infection and should receive routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine. Routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection not recommended in children 2 through 10 years of age not at increased risk.

Adolescents 11 through 18 years of age are at increased risk for meningococcal infection and should receive routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease using MenACWY vaccine. ACIP, AAP, and others recommend a dose of MenACWY vaccine in all young adolescents at 11 through 12 years of age, followed by a booster dose at 16 years of age. Catch-up vaccination recommended at first opportunity for all older adolescents 13 through 18 years of age not vaccinated at 11 through 12 years of age. If first dose of MenACWY vaccine given at 13 through 15 years of age, a booster dose is recommended at 16 through 18 years of age; booster dose not needed if first dose given at ≥16 years of age.

College freshmen living in residence halls are at increased risk for meningococcal infection and should receive at least 1 dose of MenACWY vaccine within 5 years before college entry. Preferred timing is on or after their 16th birthday; if a dose was given prior to the 16th birthday, a booster dose should be given before enrollment.

Individuals with persistent complement component deficiencies (e.g., inherited or chronic deficiencies in C3, C5–C9, properdin, factor D, factor H) or anatomic or functional asplenia (e.g., sickle cell disease) and those receiving a complement inhibitor (e.g., eculizumab, ravulizumab) are at increased risk for invasive meningococcal disease, and ACIP, AAP, and others recommend routine age-appropriate primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using age-appropriate MenACWY vaccine. If not previously vaccinated, individuals undergoing elective splenectomy should receive MenACWY vaccine ≥14 days before surgery whenever possible.

HIV-infected individuals are at increased risk for invasive meningococcal disease, and ACIP, AAP, and others recommend routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using age-appropriate MenACWY vaccine in all HIV-infected adults, adolescents, children, and infants ≥2 months of age. Consider that vaccines may be less immunogenic in immunocompromised individuals.

Military recruits are at increased risk for meningococcal disease and should receive MenACWY vaccine.

Travelers to and residents of areas where N. meningitidis is hyperendemic or epidemic are at risk for exposure to meningococcal disease and should be vaccinated against meningococcal serogroups A, C, Y, and W-135 infection. Although reported worldwide, highest incidence of meningococcal disease occurs in sub-Saharan Africa in area known as the “meningitis belt”; meningococcal disease is hyperendemic in this region with epidemics occurring periodically during dry season (December through June). Historically, serogroup A was the predominant cause of meningococcal disease outbreaks in the meningitis belt; endemic disease and outbreaks are now most commonly caused by serogroups C, W, and X. ACIP, AAP, CDC, and others recommend age-appropriate primary immunization against meningococcal serogroups A, C, Y, and W-135 disease for individuals ≥2 months of age who will be traveling to or residing in hyperendemic or epidemic areas, including the meningitis belt during dry season, especially if prolonged contact with local populations is expected. In those previously vaccinated, booster dose of MenACWY vaccine recommended if it has been ≥5 years since last dose of meningococcal vaccine. Officials in Saudi Arabia require that individuals traveling to their country for annual Hajj and Umrah pilgrimages must have documentation indicating vaccination against meningococcal serogroups A, C, Y, and W-135 administered ≥10 days and ≤3 years (unconjugated polysaccharide vaccine) or ≤5 years (conjugated polysaccharide vaccine) prior to arrival in Saudi Arabia. Consult international health clinics for travelers, state health departments, CDC at 877-394-8747, or CDC Travelers’ Health website ([Web]) for most recent information concerning geographic areas for which vaccination against meningococcal disease is recommended.

Household and other close contacts of individuals with invasive meningococcal disease are at increased risk for meningococcal infection. Whenever a case of invasive meningococcal disease occurs, anti-infective prophylaxis (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is indicated for close contacts of index case (e.g., household contacts, day-care center contacts, individuals exposed to index case’s oropharyngeal secretions) and is principal means of preventing secondary cases. In some situations, MenACWY vaccine may be recommended as an adjunct to anti-infective prophylaxis.

Outbreak Control

Whenever sporadic or cluster cases or outbreaks of meningococcal disease occur in US, anti-infective prophylaxis (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is the principal means of preventing secondary cases in household and other close contacts.

MenACWY vaccine does not stimulate immunity to meningococcal infection caused by serogroup B and is not indicated for meningococcal serogroup B outbreaks.

Meningococcal Groups A, C, Y, and W-135 Vaccine Dosage and Administration

Administration

MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT): Administer IM. Do not administer sub-Q, IV, or intradermally.

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination. Occurs most frequently in adolescents and young adults. Have procedures in place to avoid falling injury and restore cerebral perfusion following syncope. Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination. If syncope occurs, observe patient until symptoms resolve.

Usually can be given concurrently with other age-appropriate vaccines; however, do not give MenACWY-D concurrently with pneumococcal 13-valent conjugate vaccine (PCV13) in individuals with anatomic or functional asplenia. (See Specific Drugs under Interactions.)

When multiple vaccines are administered during a single health-care visit, give each parenteral vaccine using separate syringes and different injection sites. Separate injection sites by ≥1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.

IM Administration

Depending on patient age, administer IM into deltoid muscle or anterolateral thigh.

Infants <12 months of age: Preferably give IM injection into anterolateral thigh. In certain circumstances (e.g., physical obstruction at other sites and no reasonable indication to defer the vaccine dose), may consider IM injection into gluteal muscle using care to identify anatomical landmarks prior to injection.

Infants and children 1 through 2 years of age: Preferably give IM injection into anterolateral thigh; alternatively, deltoid muscle can be used if muscle mass is adequate.

Adults, adolescents, and children ≥3 years of age: Preferably give IM injection into deltoid muscle; alternatively, anterolateral thigh can be used.

To ensure delivery into muscle, make IM injections at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, thickness of adipose tissue and muscle at injection site, and injection technique. Consider anatomic variability, especially in the deltoid; use clinical judgment to avoid inadvertent underpenetration or overpenetration of muscle.

MenACWY-D (Menactra)

Administer by IM injection.

Do not dilute.

Shake well prior to use. Should appear as a clear to slightly turbid liquid; discard if it contains particulate matter, appears discolored, or cannot be resuspended with thorough agitation.

Does not contain thimerosal or any other preservative.

Do not mix with any other vaccine.

MenACWY-CRM (Menveo)

Administer by IM injection.

Supplied by manufacturer as 2 components that must be combined prior to administration: single-dose vial containing meningococcal A conjugate component (MenA) in lyophilized form and single-dose vial containing liquid meningococcal C, Y, and W-135 conjugate component (MenCYW-135).

Withdraw entire contents of vial containing liquid component into a syringe and inject into vial containing lyophilized component. Invert vial; shake well until completely dissolved.

Reconstituted vaccine should be a clear, colorless solution; do not use if it contains particulate matter or appears discolored.

Does not contain thimerosal or any other preservative.

Use immediately after reconstitution; may be stored at 2–25°C for up to 8 hours. Prior to administration, shake vial of reconstituted vaccine well. (See Storage under Stability.)

Do not mix individual components or reconstituted vaccine with any other vaccine or diluent.

MenACWY-TT (MenQuadfi)

Administer by IM injection.

Do not dilute.

Should appear as a clear, colorless solution; do not use if it contains particulate matter or appears discolored.

Does not contain thimerosal or any other preservative.

Dosage

Dosage schedule (i.e., number and timing of doses for primary immunization) and specific vaccine administered (MenACWY-D, MenACWY-CRM, MenACWY-TT) depend on individual’s age, immunization status, and risk factors. Follow age-appropriate recommendations for specific preparation used.

ACIP states that MenACWY-D, MenACWY-CRM, and MenACWY-TT can be used interchangeably. ACIP also states that if the MenACWY vaccine used previously is not available or not known, any age-appropriate MenACWY vaccine can be used for subsequent doses.

If interruptions or delays result in an interval between vaccine doses longer than recommended, ACIP states additional doses or starting vaccination series over not necessary.

Pediatric Patients

Preexposure Vaccination Against Meningococcal Serogroups A, C, Y, and W-135 in High-risk Groups

Infants 2 through 23 Months of Age (MenACWY-CRM; Menveo)

Each dose is 0.5 mL.

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: Series of 4 doses. Give doses at 2, 4, 6, and 12 months of age.

Primary immunization in previously unvaccinated infants 7 through 23 months of age at increased risk because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: 2-dose regimen. Give second dose after first birthday and ≥3 months (12 weeks) after first dose.

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 3 years after completion of primary immunization series and every 5 years thereafter.

Infants 9 through 23 Months of Age (MenACWY-D; Menactra)

Each dose is 0.5 mL.

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: Give 2 doses 3 months apart (minimum 8 weeks apart). If necessary (e.g., before travel), doses can be given 2 months apart.

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 3 years after completion of primary immunization series and every 5 years thereafter.

Children 2 through 10 Years of Age (MenACWY-D; Menactra, MenACWY-CRM; Menveo, MenACWY-TT; MenQuadfi)

Each dose is 0.5 mL.

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and others recommend 2 doses of MenACWY vaccine given 2 months apart (minimum 8 weeks apart).

Primary immunization in those at increased risk because they are travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and AAP recommend a single dose of MenACWY vaccine.

Booster doses in those who received primary immunization at 2 through 6 years of age and remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 3 years after completion of primary immunization series and every 5 years thereafter.

Booster doses in those who received primary immunization at ≥7 years of age and remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 5 years after completion of primary immunization series and every 5 years thereafter.

MenACWY-D and MenACWY-TT: Manufacturers state a single dose can be used for primary immunization.

MenACWY-CRM: Manufacturer states a single dose can be used for primary immunization and those 2–5 years of age at continued high risk can receive a second dose 2 months after first dose.

Adolescents 11 through 18 Years of Age (MenACWY-D; Menactra, MenACWY-CRM; Menveo, MenACWY-TT; MenQuadfi)

Each dose is 0.5 mL.

Routine primary immunization in adolescents: ACIP, AAP, and others recommend a primary dose of MenACWY vaccine at 11 through 12 years of age, followed by a booster dose at 16 years of age.

Catch-up vaccination recommended at first opportunity for all adolescents 13 through 18 years of age not vaccinated at 11 through 12 years of age. If first dose of MenACWY vaccine given at 13 through 15 years of age, give a booster dose at 16 through 18 years of age (≥8 weeks after first dose); booster dose not needed if first dose given at ≥16 years of age.

Primary immunization in adolescents 11 through 18 years of age at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and others recommend 2 doses of MenACWY vaccine given 2–3 months apart (minimum 8 weeks apart). Manufacturers state a single dose can be used for primary immunization.

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine every 5 years. Manufacturers state a booster dose can be given if it has been at least 4 years since the prior dose.

Adults

Preexposure Vaccination Against Meningococcal Serogroups A, C, Y, and W-135 in High-risk Groups

Adults 19 through 55 Years of Age (MenACWY-D; Menactra, MenACWY-CRM; Menveo, MenACWY-TT; MenQuadfi)

Each dose is 0.5 mL.

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP and others recommend 2 doses of MenACWY vaccine given 2–3 months apart (minimum 8 weeks apart). Manufacturers state a single dose can be used for primary immunization.

Primary immunization in those at increased risk because they are health-care or laboratory personnel, military recruits, or travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and others recommend a single dose of MenACWY vaccine.

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and others recommend a booster dose of MenACWY vaccine every 5 years. Manufacturers state a booster dose can be given if it has been at least 4 years since the prior dose.

Adults ≥56 Years of Age (MenACWY-D; Menactra† [off-label], MenACWY-CRM; Menveo† [off-label], MenACWY-TT; MenQuadfi)

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP and others recommend 2 doses of MenACWY vaccine given ≥2 months apart (minimum 8 weeks apart). Manufacturers state a single dose can be used for primary immunization.

Primary immunization in those at increased risk because they are health-care or laboratory personnel, military recruits, or travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and others recommend a single dose of MenACWY vaccine.

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and others recommend a booster dose of MenACWY vaccine every 5 years. Manufacturers state a booster dose can be given if it has been at least 4 years since the prior dose.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

MenACWY-D and MenACWY-CRM: Although not labeled by FDA for use in adults ≥56 years of age^{† [off-label]}, including those ≥65 years of age, ACIP states can be used when primary or booster immunization indicated in this age group.

MenACWY-TT is labeled by FDA for use in adults ≥56 years of age, including those ≥65 years of age.

Contraindications

• MenACWY-D (Menactra): Severe allergic reaction (e.g., anaphylaxis) after previous dose of the vaccine, any vaccine component, or any vaccine containing meningococcal capsular polysaccharide, diphtheria toxoid, or diphtheria CRM₁₉₇.

• MenACWY-CRM (Menveo): Severe allergic reaction (e.g., anaphylaxis) after previous dose of the vaccine or any vaccine containing meningococcal antigens, diphtheria toxoid, or diphtheria CRM₁₉₇.

• MenACWY-TT (MenQuadfi): Severe allergic reaction to any vaccine component or after a previous dose of the vaccine or any vaccine containing tetanus toxoid.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

MenACWY-D: Hypersensitivity reactions (e.g., anaphylactic/anaphylactoid reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension, erythema multiforme) reported rarely.

MenACWY-CRM: Hypersensitivity reactions reported.

MenACWY-TT: Hypersensitivity reactions possible.

Prior to administration of MenACWY vaccine, take all known precautions to prevent adverse reactions, including a review of patient’s history with respect to possible hypersensitivity to the vaccine, vaccine components, or similar vaccines.

Epinephrine and other appropriate agents and equipment should be readily available in case anaphylaxis or other serious allergic reaction occurs.

Guillain-Barré Syndrome

MenACWY-D: Postmarketing reports of Guillain-Barré syndrome (GBS) temporally associated with vaccination.

GBS is a serious neurologic disorder involving inflammatory demyelination of peripheral nerves and may occur spontaneously or after certain antecedent events (e.g., infections). Characterized by subacute onset of progressive, symmetrical weakness in legs and arms, with loss of reflexes. Sensory abnormalities, cranial nerve involvement, and paralysis of respiratory muscles may also develop. GBS can be fatal; up to 20% of hospitalized patients may have prolonged disability.

Based on data from one postmarketing, retrospective, safety study that evaluated risk of GBS following administration of MenACWY-D, attributable risk of GBS ranged from 0–5 additional cases per 1 million vaccinees within the 6-week period following vaccination. In another retrospective, cohort study involving 12.6 million individuals 11–21 years of age, >1.4 million doses of MenACWY-D had been administered and there were 99 confirmed cases of GBS (5.4 cases per 1 million vaccinees); none of these GBS cases occurred within the 6-week period following vaccination.

MenACWY-D: Manufacturer states that individuals with a history of GBS may be at increased risk of GBS following administration of the vaccine and potential benefits and risks should be considered when deciding whether to administer the vaccine in such individuals.

MenACWY-CRM and MenACWY-TT: Manufacturers state that, because GBS reported in temporal relationship following administration of another US quadrivalent polysaccharide meningococcal conjugate vaccine, take into account potential benefits and risks when deciding whether to administer the vaccine in an individual with a history of GBS.

After reviewing available safety data for MenACWY vaccine, ACIP concluded that benefits of vaccination against meningococcal serogroups A, C, Y, and W-135 outweigh potential increased risk for GBS. ACIP states that, although early postmarketing surveillance raised concern of a potential risk for GBS, subsequent evaluations have not identified an increased risk for GBS after MenACWY-D vaccination.

Bell's Palsy

MenACWY-CRM: Postmarketing reports of Bell's palsy in temporal association with administration of MenACWY-CRM in adolescents and young adults 11–21 years of age. Symptoms of Bell's palsy resolved in all reported cases to date. In 6 of 8 cases that occurred within 84 days after vaccination, MenACWY-CRM had been administered concomitantly with ≥1 other vaccine (i.e., human papillomavirus [HPV] vaccine; tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed [Tdap]; influenza vaccine).

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy. Consider possibility that immune responses to vaccines and efficacy may be reduced in these individuals.

HIV-infected individuals ≥2 months of age: Age-appropriate regimen of MenACWY vaccine recommended by ACIP, AAP, and others for routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection.

Individuals with functional or anatomic asplenia (including sickle cell disease): Age-appropriate regimen of MenACWY vaccine recommended by ACIP and others for routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection. When planning immunization against meningococcal disease and pneumococcal disease in individuals with anatomic or functional asplenia, consider that MenACWY-D should not be given concomitantly with or within 4 weeks after PCV13 (see Specific Drugs under Interactions).

Individuals scheduled for elective splenectomy: Give MenACWY vaccine ≥14 days prior to surgery; if not given prior to surgery, administer as soon as possible ≥2 weeks after the procedure when patient's condition is stable.

Individuals with persistent complement component deficiency and those receiving treatment with a complement inhibitor (e.g., eculizumab, ravulizumab): Increased risk for invasive disease caused by meningococcal serogroups A, C, Y, and W-135, even if they develop antibodies following vaccination with MenACWY vaccine. Life-threatening and fatal meningococcal infections have occurred in patients receiving eculizumab or ravulizumab. Administer MenACWY vaccines ≥2 weeks prior to the first dose of eculizumab or ravulizumab, unless risks of delaying initiation of drug outweigh risks of meningococcal infection.

Individuals receiving immunosuppressive therapy: Generally give inactivated vaccines prior to initiation of immunosuppressive therapy or defer until immunosuppressive therapy discontinued. (See Immunosuppressive Agents under Interactions.)

Concomitant Illness

Base decision to administer or delay vaccination in an individual with a current or recent acute illness on severity of symptoms and etiology of the illness.

ACIP states mild acute illness generally does not preclude vaccination.

ACIP states moderate or severe acute illness (with or without fever) is a precaution for vaccination; defer vaccines until individual has recovered from the acute phase of the illness. This avoids superimposing vaccine adverse effects on the underlying illness or mistakenly concluding that a manifestation of the underlying illness resulted from vaccine administration.

Individuals with Bleeding Disorders

Advise individuals who have bleeding disorders or are receiving anticoagulant therapy and/or their family members about the risk of hematoma from IM injections.

ACIP states IM vaccines may be given to such individuals if a clinician familiar with the patient’s bleeding risk determines that the vaccines can be administered IM with reasonable safety. In these cases, use a fine needle (23 gauge) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes. In individuals receiving therapy for hemophilia, IM vaccines can be scheduled for shortly after a dose of such therapy.

Limitations of Vaccine Effectiveness

MenACWY vaccine may not protect all vaccine recipients against meningococcal serogroups A, C, Y, and W-135 infection.

MenACWY vaccine provides protection only against those meningococcal serogroups represented in the vaccine (i.e., serogroups A, C, Y, W-135). Will not prevent infection caused by other serogroups (e.g., serogroup B) and will not prevent infections caused by other pathogens.

MenACWY-TT: Immunization with the vaccine is not a substitute for routine immunization against tetanus.

Duration of Immunity

Duration of immunity after primary immunization with MenACWY vaccine (MenACWY-D. MenACWY-CRM, MenACWY-TT) or previously available unconjugated vaccine (MPSV4) not fully determined.

MenACWY vaccine is expected to provide a longer duration of protection than the previously available unconjugated vaccine (MPSV4).

Meningococcal antigens in MenACWY-D. MenACWY-CRM, and MenACWY-TT are conjugated to protein carriers containing T-cell epitopes. This may result in improved primary response to the antigens and strong anamnestic response after reexposure to the antigens.

Booster doses of MenACWY vaccine may be necessary in individuals who previously received MenACWY or MPSV4 (no longer available in the US) and continue to be at prolonged increased risk for exposure to meningococcal serogroups A, C, Y, and W-135 infection.

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune response in vaccinees.

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained. (See Storage under Stability.)

Do not administer meningococcal vaccine that has been mishandled or has not been stored at the recommended temperature.

If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.

Specific Populations

Pregnancy

No adequate and well-controlled studies evaluating MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) in pregnant women.

MenACWY-D: Available data suggest that rates of major birth defects and miscarriage in women who received the vaccine 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates. Animal studies have not revealed any evidence of harm to the fetus. Pregnancy registry at 800-822-2463.

MenACWY-CRM: Data from a pregnancy registry conducted from 2014–2017 do not suggest an increased risk of major birth defects or miscarriage in women who received the vaccine within 28 days prior to conception or during pregnancy. Animal reproduction studies have not revealed evidence of harm to the fetus.

MenACWY-TT: Animal reproduction studies performed in female rabbits did not reveal evidence of harm to the fetus or adverse effects on postnatal development. Report any exposure to MenACWY-TT that occurs during pregnancy to the manufacturer’s pregnancy registry at 800-822-2463.

ACIP and AAP state MenACWY vaccine may be used during pregnancy if indicated. Although data are limited, postmarketing surveillance has not identified any concerning safety signals regarding use of MenACWY vaccines during pregnancy.

Lactation

Not known whether antigens contained in MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) are distributed into milk.

Manufacturers state consider benefits of breast-feeding and the importance of MenACWY vaccine to the woman; also consider potential adverse effects on breast-fed child from the vaccine or from the underlying maternal condition (i.e., susceptibility to meningococcal infection).

ACIP states that breast-feeding women should receive MenACWY vaccine if indicated.

Pediatric Use

MenACWY-D (Menactra): Safety and efficacy not established in pediatric patients <9 months of age.

MenACWY-CRM (Menveo): Safety and efficacy not established in pediatric patients <2 months of age.

MenACWY-TT (MenQuadfi): Safety and efficacy not established in pediatric patients <2 years of age.

Apnea reported following IM administration of vaccines in some infants born prematurely. Base decisions regarding when to administer an IM vaccine in premature infants on consideration of the individual infant's medical status and potential benefits and possible risks of vaccination.

Geriatric Use

MenACWY-D (Menactra): Safety and efficacy not established in adults ≥56 years of age, including geriatric adults. ACIP states the vaccine may be used if indicated in this age group.

MenACWY-CRM (Menveo): Safety and efficacy not established in adults ≥56 years of age, including those ≥65 years of age. ACIP states the vaccine may be used if indicated in this age group.

MenACWY-TT (MenQuadfi): Clinical studies included 249 individuals ≥65 years of age, including 71 individuals ≥75 years of age. Antibody responses to all 4 serotypes represented in the vaccine were diminished in vaccine recipients ≥65 years of age compared with those 56–64 years of age.

Common Adverse Effects

MenACWY-D (Menactra): Injection site reactions (e.g., pain, induration, erythema, swelling), headache, fatigue, malaise, arthralgia, diarrhea, anorexia, chills, fever, vomiting, rash. Most common adverse effects in those 11 through 55 years of age after a booster dose were injection site pain and myalgia; overall rates of solicited local and systemic reactions similar to those observed after a primary dose.

MenACWY-CRM (Menveo): Injection site reactions (tenderness, erythema), irritability, sleepiness, persistent crying, change in eating habits, vomiting, diarrhea in infants 2 through 23 months of age; injection site reactions (pain, erythema, induration), irritability, sleepiness, malaise, headache in children 2 through 10 years of age; injection site pain, headache, myalgia, malaise, nausea in adults and adolescents. Most common adverse effects after a booster dose in those 15 through 55 years of age were injection site pain and fatigue.

MenACWY-TT (MenQuadfi): Injection site reactions (e.g., pain, erythema, swelling), myalgia, headache, malaise. Most common adverse effects after a booster dose in those ≥15 years of age were injection site pain, myalgia, and malaise; overall rates of solicited local and systemic reactions similar to those observed after a primary dose.

Administration

MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT): Administer IM. Do not administer sub-Q, IV, or intradermally.

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination. Occurs most frequently in adolescents and young adults. Have procedures in place to avoid falling injury and restore cerebral perfusion following syncope. Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination. If syncope occurs, observe patient until symptoms resolve.

Usually can be given concurrently with other age-appropriate vaccines; however, do not give MenACWY-D concurrently with pneumococcal 13-valent conjugate vaccine (PCV13) in individuals with anatomic or functional asplenia. (See Specific Drugs under Interactions.)

When multiple vaccines are administered during a single health-care visit, give each parenteral vaccine using separate syringes and different injection sites. Separate injection sites by ≥1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.

IM Administration

Depending on patient age, administer IM into deltoid muscle or anterolateral thigh.

Infants <12 months of age: Preferably give IM injection into anterolateral thigh. In certain circumstances (e.g., physical obstruction at other sites and no reasonable indication to defer the vaccine dose), may consider IM injection into gluteal muscle using care to identify anatomical landmarks prior to injection.

Infants and children 1 through 2 years of age: Preferably give IM injection into anterolateral thigh; alternatively, deltoid muscle can be used if muscle mass is adequate.

Adults, adolescents, and children ≥3 years of age: Preferably give IM injection into deltoid muscle; alternatively, anterolateral thigh can be used.

To ensure delivery into muscle, make IM injections at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, thickness of adipose tissue and muscle at injection site, and injection technique. Consider anatomic variability, especially in the deltoid; use clinical judgment to avoid inadvertent underpenetration or overpenetration of muscle.

MenACWY-D (Menactra)

Administer by IM injection.

Do not dilute.

Shake well prior to use. Should appear as a clear to slightly turbid liquid; discard if it contains particulate matter, appears discolored, or cannot be resuspended with thorough agitation.

Does not contain thimerosal or any other preservative.

Do not mix with any other vaccine.

MenACWY-CRM (Menveo)

Administer by IM injection.

Supplied by manufacturer as 2 components that must be combined prior to administration: single-dose vial containing meningococcal A conjugate component (MenA) in lyophilized form and single-dose vial containing liquid meningococcal C, Y, and W-135 conjugate component (MenCYW-135).

Withdraw entire contents of vial containing liquid component into a syringe and inject into vial containing lyophilized component. Invert vial; shake well until completely dissolved.

Reconstituted vaccine should be a clear, colorless solution; do not use if it contains particulate matter or appears discolored.

Does not contain thimerosal or any other preservative.

Use immediately after reconstitution; may be stored at 2–25°C for up to 8 hours. Prior to administration, shake vial of reconstituted vaccine well. (See Storage under Stability.)

Do not mix individual components or reconstituted vaccine with any other vaccine or diluent.

MenACWY-TT (MenQuadfi)

Administer by IM injection.

Do not dilute.

Should appear as a clear, colorless solution; do not use if it contains particulate matter or appears discolored.

Does not contain thimerosal or any other preservative.

Dosage

Dosage schedule (i.e., number and timing of doses for primary immunization) and specific vaccine administered (MenACWY-D, MenACWY-CRM, MenACWY-TT) depend on individual’s age, immunization status, and risk factors. Follow age-appropriate recommendations for specific preparation used.

ACIP states that MenACWY-D, MenACWY-CRM, and MenACWY-TT can be used interchangeably. ACIP also states that if the MenACWY vaccine used previously is not available or not known, any age-appropriate MenACWY vaccine can be used for subsequent doses.

If interruptions or delays result in an interval between vaccine doses longer than recommended, ACIP states additional doses or starting vaccination series over not necessary.

Pediatric Patients

Preexposure Vaccination Against Meningococcal Serogroups A, C, Y, and W-135 in High-risk Groups

Infants 2 through 23 Months of Age (MenACWY-CRM; Menveo)

Each dose is 0.5 mL.

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: Series of 4 doses. Give doses at 2, 4, 6, and 12 months of age.

Primary immunization in previously unvaccinated infants 7 through 23 months of age at increased risk because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: 2-dose regimen. Give second dose after first birthday and ≥3 months (12 weeks) after first dose.

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 3 years after completion of primary immunization series and every 5 years thereafter.

Infants 9 through 23 Months of Age (MenACWY-D; Menactra)

Each dose is 0.5 mL.

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: Give 2 doses 3 months apart (minimum 8 weeks apart). If necessary (e.g., before travel), doses can be given 2 months apart.

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 3 years after completion of primary immunization series and every 5 years thereafter.

Children 2 through 10 Years of Age (MenACWY-D; Menactra, MenACWY-CRM; Menveo, MenACWY-TT; MenQuadfi)

Each dose is 0.5 mL.

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and others recommend 2 doses of MenACWY vaccine given 2 months apart (minimum 8 weeks apart).

Primary immunization in those at increased risk because they are travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and AAP recommend a single dose of MenACWY vaccine.

Booster doses in those who received primary immunization at 2 through 6 years of age and remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 3 years after completion of primary immunization series and every 5 years thereafter.

Booster doses in those who received primary immunization at ≥7 years of age and remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 5 years after completion of primary immunization series and every 5 years thereafter.

MenACWY-D and MenACWY-TT: Manufacturers state a single dose can be used for primary immunization.

MenACWY-CRM: Manufacturer states a single dose can be used for primary immunization and those 2–5 years of age at continued high risk can receive a second dose 2 months after first dose.

Adolescents 11 through 18 Years of Age (MenACWY-D; Menactra, MenACWY-CRM; Menveo, MenACWY-TT; MenQuadfi)

Each dose is 0.5 mL.

Routine primary immunization in adolescents: ACIP, AAP, and others recommend a primary dose of MenACWY vaccine at 11 through 12 years of age, followed by a booster dose at 16 years of age.

Catch-up vaccination recommended at first opportunity for all adolescents 13 through 18 years of age not vaccinated at 11 through 12 years of age. If first dose of MenACWY vaccine given at 13 through 15 years of age, give a booster dose at 16 through 18 years of age (≥8 weeks after first dose); booster dose not needed if first dose given at ≥16 years of age.

Primary immunization in adolescents 11 through 18 years of age at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and others recommend 2 doses of MenACWY vaccine given 2–3 months apart (minimum 8 weeks apart). Manufacturers state a single dose can be used for primary immunization.

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine every 5 years. Manufacturers state a booster dose can be given if it has been at least 4 years since the prior dose.

Adults

Preexposure Vaccination Against Meningococcal Serogroups A, C, Y, and W-135 in High-risk Groups

Adults 19 through 55 Years of Age (MenACWY-D; Menactra, MenACWY-CRM; Menveo, MenACWY-TT; MenQuadfi)

Each dose is 0.5 mL.

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP and others recommend 2 doses of MenACWY vaccine given 2–3 months apart (minimum 8 weeks apart). Manufacturers state a single dose can be used for primary immunization.

Primary immunization in those at increased risk because they are health-care or laboratory personnel, military recruits, or travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and others recommend a single dose of MenACWY vaccine.

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and others recommend a booster dose of MenACWY vaccine every 5 years. Manufacturers state a booster dose can be given if it has been at least 4 years since the prior dose.

Adults ≥56 Years of Age (MenACWY-D; Menactra† [off-label], MenACWY-CRM; Menveo† [off-label], MenACWY-TT; MenQuadfi)

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP and others recommend 2 doses of MenACWY vaccine given ≥2 months apart (minimum 8 weeks apart). Manufacturers state a single dose can be used for primary immunization.

Primary immunization in those at increased risk because they are health-care or laboratory personnel, military recruits, or travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and others recommend a single dose of MenACWY vaccine.

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and others recommend a booster dose of MenACWY vaccine every 5 years. Manufacturers state a booster dose can be given if it has been at least 4 years since the prior dose.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

MenACWY-D and MenACWY-CRM: Although not labeled by FDA for use in adults ≥56 years of age^{† [off-label]}, including those ≥65 years of age, ACIP states can be used when primary or booster immunization indicated in this age group.

MenACWY-TT is labeled by FDA for use in adults ≥56 years of age, including those ≥65 years of age.

Immunosuppressive Agents

Immune responses to vaccines, including MenACWY vaccine, may be reduced in individuals receiving immunosuppressive therapy.

Generally, give inactivated vaccines ≥2 weeks prior to initiation of immunosuppressive therapy and, because of possible suboptimal response, do not give during and for certain periods of time after immunosuppressive therapy discontinued.

Time to restoration of immune competence varies depending on type and intensity of immunosuppressive therapy, underlying disease, and other factors; optimal timing for vaccine administration after discontinuance of immunosuppressive therapy not identified for every situation.

Vaccines

Although specific studies may not be available, concurrent administration with other age-appropriate vaccines, including live virus vaccines, toxoids, or inactivated or recombinant vaccines, during the same health-care visit generally is not expected to affect immunologic responses or adverse reactions to any of the preparations. (See Specific Drugs under Interactions.)

Immunization with MenACWY vaccine can be integrated with immunization against diphtheria, tetanus, pertussis, Hib, hepatitis A, hepatitis B, HPV, influenza, measles, mumps, rubella, pneumococcal disease, poliomyelitis, and varicella. Administer each parenteral vaccine using a separate syringe and different injection site.

Specific Drugs