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

Class: Vaccines
ATC Class: J07AH01
VA Class: IM100
Brands: Menactra, Menveo

Medically reviewed on Nov 26, 2018

Introduction

Inactivated (polysaccharide) vaccine.108 152 228 Commercially available in US as 2 different quadrivalent conjugated (MenACWY) vaccines: meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D; Menactra)108 and meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM; Menveo).152 Both contain A, C, Y, and W-135 capsular polysaccharide antigens extracted from Neisseria meningitidis linked to a carrier protein.108 152 228 Unconjugated meningococcal vaccine (MPSV4; Menomune)1 no longer available in US.

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.105 108 152 161 165 166 199 200 228

N. meningitidis can cause invasive meningococcal disease that usually presents as severe and potentially life-threatening meningitis and/or meningococcemia with abrupt onset;105 166 228 transmitted person to person by the respiratory route.6 105 166 228 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;105 166 228 237 approximately 67% of cases in adults and adolescents ≥11 years are caused by serogroups C, Y, or W-135.237 Although overall incidence of meningococcal disease in the US has been historically low during the last 10–15 years (about 370 cases reported to CDC during 2016),105 166 228 237 overall case fatality rate has remained 10–15% (even with appropriate anti-infective treatment)105 166 228 237 and fatality rate may be as high as 40% in those with meningococcemia.166 In addition, long-term sequelae (e.g., hearing loss, neurologic disability, digit or limb amputations) reported in 11–20% of patients.105 166 228 237 While 98% of US cases of meningococcal disease are sporadic, localized outbreaks do occur and most outbreaks have been caused by serogroups B and C.166 228

USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection in all adolescents, preferably at 11 through 12 years of age, followed by a booster dose at 16 years of age.105 199 228 Catch-up vaccination recommended at 13 through 18 years of age for those not previously vaccinated;105 199 228 catch-up vaccination also recommended for all first-year college students through 21 years of age living in residence halls who did not receive a dose of meningococcal vaccine on or after their 16th birthday.200 228 (See Preexposure Vaccination Against Meningococcal Infection in High-risk Groups under Uses.)

ACIP, AAP, and others also recommend routine primary and booster vaccination against meningococcal serogroups A, C, Y, and W-135 infection in selected infants, children, adolescents, and adults at increased risk because of certain chronic medical conditions (e.g., persistent complement component deficiencies, 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.105 155 156 161 165 199 200 228 Also recommended in some other individuals at increased risk (e.g., certain health-care and laboratory personnel, military recruits).200 228 235 (See Preexposure Vaccination Against Meningococcal Infection in High-risk Groups under Uses.)

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).105 165 199 228 235 (See Outbreak Control under Uses.)

MenACWY vaccine provides protection only against N. meningitidis serogroups represented in the vaccine (i.e., serogroups A, C, Y, W-135);105 108 152 166 228 will not prevent meningococcal infection caused by other serogroups (e.g., serogroup B) and will not prevent infections caused by other pathogens.105 108 152 166 228

ACIP and AAP do not state a preference for MenACWY-D or MenACWY-CRM; either age-appropriate vaccine can be used for primary immunization and/or revaccination or booster doses.134 199 200 228 Consider that dosage schedules (i.e., number and timing of doses for primary immunization) differ depending on which vaccine used.108 152 199 228 (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 (e.g., persistent complement component deficiencies, 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 (MenACWY-D or MenACWY-CRM).156 161 165 199 228 Routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection not recommended in infants not at increased risk.105 165

Children 2 through 10 years of age with certain chronic medical conditions (e.g., persistent complement component deficiencies, 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 (MenACWY-D or MenACWY-CRM).105 156 161 199 228 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.105 199 228

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 (MenACWY-D or MenACWY-CRM).105 199 228 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.105 199 228 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.105 199 228 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;199 228 booster dose not needed if first dose given at ≥16 years of age.199 228

College freshmen through 21 years of age living in dormitories are at increased risk for meningococcal infection and should receive primary immunization against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine (MenACWY-D or MenACWY-CRM) if they did not receive a dose at ≥16 years of age.200 228

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 eculizumab are at increased risk for invasive meningococcal disease,53 67 85 105 228 236 and ACIP, AAP, and others recommend routine age-appropriate primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine (MenACWY-D or MenACWY-CRM).105 135 199 200 228 If not previously vaccinated, individuals undergoing elective splenectomy should receive MenACWY vaccine ≥14 days before surgery whenever possible.134 (See Individuals with Altered Immunocompetence under Cautions.)

HIV-infected individuals are at increased risk for invasive meningococcal disease,156 161 166 228 and ACIP, AAP, CDC, NIH, HIV Medicine Association of IDSA, and others recommend routine age-appropriate primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection in all HIV-infected adults, adolescents, children, and infants ≥2 months of age using MenACWY vaccine (MenACWY-D or MenACWY-CRM).135 155 156 161 199 200 Because HIV-infected individuals may not respond optimally to a single dose,228 use 2-dose primary series of MenACWY vaccine in all previously unvaccinated HIV-infected individuals ≥2 years of age.161 199 200 228 HIV-infected individuals ≥2 years of age who previously received only a single dose for primary immunization should receive a booster dose of MenACWY vaccine at the earliest opportunity (provided it has been ≥8 weeks after previous dose).161 HIV-infected infants 2 months to <2 years of age should receive age-appropriate multiple-dose primary series of MenACWY vaccine.161 Consider that vaccines may be less immunogenic in immunocompromised individuals.108 134 152 228 (See Individuals with Altered Immunocompetence under Cautions.)

Health-care and laboratory personnel with certain chronic medical conditions known to increase risk for meningococcal disease (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection) and those who are routinely exposed to isolates of N. meningitidis or will be traveling to areas where meningococcal disease is hyperendemic or epidemic should be vaccinated against meningococcal serogroups A, C, Y, and W-135 disease.200 228 235 ACIP and Healthcare Infection Control Practices Advisory Committee (HICPAC) state that routine immunization against meningococcal serogroups A, C, Y, and W-135 disease is not recommended in other health-care personnel.235 However, in the setting of a community or institutional outbreak of meningococcal disease, vaccination of health-care personnel may be indicated if the outbreak is caused by a meningococcal serogroup represented in the vaccine.228 235 Regardless of vaccination status, postexposure anti-infective prophylaxis against meningococcal infection (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is recommended for all health-care personnel who have had unprotected (i.e., without wearing a mask) intensive contact (i.e., mouth-to-mouth resuscitation, endotracheal intubation or endotracheal tube management) with an infected patient.228 235

Military recruits are at increased risk for meningococcal disease228 and should receive MenACWY vaccine.200 228

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.105 115 228 Although reported worldwide, highest incidence of meningococcal disease occurs in sub-Saharan Africa in area known as the “meningitis belt” extending from Senegal and Guinea eastward to Ethiopia;43 44 45 115 228 meningococcal disease is hyperendemic in this region with epidemics occurring periodically during dry season (December through June).115 Historically, meningococcal disease outbreaks in the meningitis belt were caused by serogroup A; recent outbreaks have primarily been caused by serogroups C and W, although serogroup X outbreaks also reported.115 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.115 199 200 228 In those previously vaccinated, booster dose of MenACWY vaccine recommended if it has been ≥5 years since last dose of meningococcal vaccine.228 Officials in Saudi Arabia require that individuals traveling to their country for annual Hajj and Umrah pilgrimages or for seasonal work in Hajj ad Umrah zones must have a valid vaccination certificate 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.115 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.115 228

Household and other close contacts of individuals with invasive meningococcal disease are at increased risk for meningococcal infection.14 62 79 105 228 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)79 105 228 and is principal means of preventing secondary cases.79 90 228 In some situations, MenACWY vaccine may be recommended as an adjunct to anti-infective prophylaxis.49 62 66 90 105 228

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.90 105 228

Mass vaccination programs may be indicated in some meningococcal outbreaks if the outbreak is caused by a vaccine-preventable serogroup of N. meningitidis.105 228 Decision to implement such vaccination campaigns depends on whether the occurrence of >1 case represents an outbreak or an unusual clustering of endemic disease.228 If an outbreak occurs in the US, public health authorities will determine whether mass vaccinations (with or without mass anti-infective prophylaxis) are indicated.105 228

MenACWY vaccine (MenACWY-D or MenACWY-CRM) does not stimulate immunity to meningococcal infection caused by serogroup B and is not indicated for meningococcal serogroup B outbreaks.108 152 166 228

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

Administration

MenACWY vaccine (MenACWY-D or MenACWY-CRM): Administer IM.108 152 Do not administer sub-Q, IV, or intradermally.108 152

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination.134 152 Occurs most frequently in adolescents and young adults.134 Have procedures in place to avoid falling injury and restore cerebral perfusion following syncope.134 Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination.134 If syncope occurs, observe patient until symptoms resolve.134

Usually can be given concurrently with other age-appropriate vaccines;105 134 228 however, do not give MenACWY-D concurrently with pneumococcal 13-valent conjugate vaccine (PCV13) in infants and children with anatomic or functional asplenia.105 199 228 (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.134 228 Separate injection sites by ≥1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.134

IM Administration

Depending on patient age, administer IM into deltoid muscle or anterolateral thigh.134

Infants <12 months of age: Preferably give IM injection into anterolateral thigh.134 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.134

Infants and children 1 through 2 years of age: Preferably give IM injection into anterolateral thigh;134 alternatively, deltoid muscle can be used if muscle mass is adequate.134

Adults, adolescents, and children ≥3 years of age: Preferably give IM injection into deltoid muscle;134 152 alternatively, anterolateral thigh can be used.134

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.134 149 150 Consider anatomic variability, especially in the deltoid;149 150 use clinical judgment to avoid inadvertent underpenetration or overpenetration of muscle.149 150

MenACWY-D (Menactra)

Administer only by IM injection.108

Do not dilute.108

Shake well prior to use.108 Should appear as a clear to slightly turbid liquid;108 discard if it contains particulate matter, appears discolored, or cannot be resuspended with thorough agitation.108

Do not mix with any other vaccine.108

MenACWY-CRM (Menveo)

Administer only by IM injection.152

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).152

Withdraw entire contents of vial containing liquid component into a syringe and inject into vial containing lyophilized component.152 Invert vial;152 shake well until completely dissolved.152

Reconstituted vaccine should be a clear, colorless solution;152 do not use if it contains particulate matter or appears discolored.152

Use immediately after reconstitution;152 may be stored at ≤25°C for up to 8 hours.152 (See Storage under Stability.)

Do not mix individual components or reconstituted vaccine with any other vaccine or diluent.152

Dosage

Dosage schedule (i.e., number and timing of doses for primary immunization) and specific vaccine administered (MenACWY-D or MenACWY-CRM) depend on individual’s age, immunization status, and risk factors.108 152 228 Follow age-appropriate recommendations for specific preparation used.108 152 228

Limited data suggest that MenACWY-D and MenACWY-CRM can be used interchangeably.228 ACIP 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.134 161

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.134

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)
IM

Each dose is 0.5 mL.152

Primary immunization in those at increased risk because of certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection) or travel to areas with hyperendemic or epidemic meningococcal disease: Use a series of 4 doses.152 161 165 199 Give doses at 2, 4, 6, and 12 months of age.152 199

Primary immunization in previously unvaccinated infants 7 through 23 months of age at increased risk because of certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection) or travel to areas with hyperendemic or epidemic meningococcal disease: Use 2-dose regimen.152 161 199 Give second dose after first birthday and ≥3 months (12 weeks) after first dose.152 161 199

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.105 161 228

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

Each dose is 0.5 mL.108

Primary immunization in those at increased risk because of certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection) or travel to areas with hyperendemic or epidemic meningococcal disease: Give 2 doses 3 months apart (minimum 8 weeks apart).105 108 161 199 228 If necessary (e.g., before travel), ACIP and AAP state the doses can be given 2 months apart.105 199

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.105 161 228

Children 2 through 10 Years of Age (MenACWY-D; Menactra or MenACWY-CRM; Menveo)
IM

Each dose is 0.5 mL.108 152

Primary immunization in those at increased risk because of certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection): ACIP, AAP, and others recommend 2 doses of MenACWY vaccine given 2–3 months apart (minimum 8 weeks apart).105 161 199 228

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.105 228

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.105 161 228

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.105 161 228

MenACWY-D: Manufacturer states a single dose can be used for primary immunization.108

MenACWY-CRM: Manufacturer states a single dose can be used for primary immunization and a second dose may be given 2 months after first dose in those 2 through 5 years of age at increased risk.152

Adolescents 11 through 18 Years of Age (MenACWY-D; Menactra or MenACWY-CRM; Menveo)
IM

Each dose is 0.5 mL.108 152

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.105 199 228

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.105 199 228 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);199 228 booster dose not needed if first dose given at ≥16 years of age.199 228

Primary immunization in adolescents 11 through 18 years of age at increased risk because of certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection): ACIP, AAP, and others recommend 2 doses of MenACWY vaccine given 2–3 months apart (minimum 8 weeks apart).105 161 199 228 For those who remain at prolonged increased risk for meningococcal disease, give booster dose of MenACWY vaccine every 5 years.161 166 200 228

Manufacturers state a single dose can be used for primary immunization.108 152

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 or MenACWY-CRM; Menveo)
IM

Each dose is 0.5 mL.108 152

Primary immunization in those at increased risk because of certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection): ACIP and others recommend 2 doses of MenACWY vaccine given 2–3 months apart (minimum 8 weeks apart).161 200 228

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.200 228

Manufacturers state a single dose can be used for primary immunization.108 152

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.161 200 228

Adults ≥56 Years of Age (MenACWY-D; Menactra or MenACWY-CRM; Menveo)
IM

Primary immunization in those at increased risk because of certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection): ACIP and others recommend 2 doses of MenACWY vaccine given ≥2 months apart (minimum 8 weeks apart).200 228

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.200 228

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.200 228

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,108 152 ACIP states use MenACWY vaccine when primary or booster immunization indicated in this age group.135 161 228 (See Geriatric Use under Cautions.)

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

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 CRM197.108

  • 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 CRM197.152

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.108 146 152

MenACWY-CRM: Hypersensitivity reactions reported.152

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.108

Epinephrine and other appropriate agents and equipment should be readily available in case anaphylaxis or other serious allergic reaction occurs.108 152

Guillain-Barré Syndrome

MenACWY-D: Postmarketing reports of Guillain-Barré syndrome (GBS) temporally associated with vaccination.108 110 111 122 123 124 238

GBS is a serious neurologic disorder involving inflammatory demyelination of peripheral nerves and may occur spontaneously or after certain antecedent events (e.g., infections).110 111 Characterized by subacute onset of progressive, symmetrical weakness in legs and arms, with loss of reflexes.110 Sensory abnormalities, cranial nerve involvement, and paralysis of respiratory muscles may also develop.110 GBS can be fatal; up to 20% of hospitalized patients may have prolonged disability.110

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.108 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);238 none of these GBS cases occurred within the 6-week period following vaccination.238

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.108

MenACWY-CRM: Manufacturer states 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.152

Because of known risk for meningococcal exposure and limited data indicating an association between MenACWY-D vaccination and GBS, CDC continues to recommend routine vaccination with MenACWY vaccine for adolescents, first-year college students living in dormitories, and other populations at increased risk for meningococcal serogroups A, C, Y, and W-135 infection.123 124 228 After reviewing available safety data, ACIP concluded that the benefits of meningococcal vaccination outweigh risks of GBS recurrence in individuals with a history of GBS.228

Clinicians should remain alert to possibility of vaccine-associated GBS and report any suspected cases to VAERS at 800-822-7967 or [Web].110 111 123 124

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.152 239 Symptoms of Bell's palsy resolved in all reported cases to date.152 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).152 239

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.105 134 135 161 228 Consider possibility that immune responses to vaccines and efficacy may be reduced in these individuals.105 108 134 135 152 228

Manufacturers state that immunogenicity of MenACWY-D and MenACWY-CRM not specifically studied in immunocompromised individuals.108 152

HIV-infected individuals ≥2 months of age: Age-appropriate regimen of MenACWY vaccine recommended by ACIP, AAP, CDC, NIH, HIV Medicine Association of IDSA, and others for routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection.105 135 155 156 161 (See Preexposure Vaccination Against Meningococcal Infection in High-risk Groups under Uses.)

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.105 134 135 (See Preexposure Vaccination Against Meningococcal Infection in High-risk Groups under Uses.). When planning immunization against meningococcal disease and pneumococcal disease in infants and children 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).105 134

Individuals scheduled for elective splenectomy: Give MenACWY vaccine ≥14 days prior to surgery;105 134 if not given prior to surgery, administer as soon as possible ≥2 weeks after the procedure when patient's condition is stable.105 134

Individuals receiving immunosuppressive therapy: Generally give inactivated vaccines prior to initiation of immunosuppressive therapy or defer until immunosuppressive therapy discontinued.105 134 (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.108 134

ACIP states mild acute illness generally does not preclude vaccination.134

ACIP states moderate or severe acute illness (with or without fever) is a precaution for vaccination;134 defer vaccines until individual has recovered from the acute phase of the illness.134 This avoids superimposing vaccine adverse effects on the underlying illness or mistakenly concluding that a manifestation of the underlying illness resulted from vaccine administration.134

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.134

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.134 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.134 In individuals receiving therapy for hemophilia, IM vaccines can be scheduled for shortly after a dose of such therapy.134

Limitations of Vaccine Effectiveness

MenACWY vaccine (MenACWY-D or MenACWY-CRM) may not protect all vaccine recipients against meningococcal serogroups A, C, Y, and W-135 infection.105 108

MenACWY vaccine provides protection only against those meningococcal serogroups represented in the vaccine (i.e., serogroups A, C, Y, W-135).105 108 152 166 228 Will not prevent infection caused by other serogroups (e.g., serogroup B) and will not prevent infections caused by other pathogens.105 108 152 166 228

While there is evidence that meningococcal vaccines can stimulate antibody responses in individuals with inherited complement deficiencies and individuals without spleens, efficacy not fully established in these individuals and MenACWY vaccine may not provide complete protection.134 (See Preexposure Vaccination Against Meningococcal Infection in High-risk Groups under Uses.)

Duration of Immunity

Duration of immunity after primary immunization with MenACWY vaccine (MenACWY-D or MenACWY-CRM) or previously available unconjugated vaccine (MPSV4) not fully determined.105 108 152 228

MenACWY vaccine (MenACWY-D or MenACWY-CRM) is expected to provide a longer duration of protection than the previously available unconjugated vaccine (MPSV4).228

Meningococcal antigens in MenACWY-D and MenACWY-CRM are conjugated to protein carriers containing T-cell epitopes.108 152 228 This may result in improved primary response to the antigens and strong anamnestic response after reexposure to the antigens.108 134 152 228

Because of waning immunity, a single dose of MenACWY vaccine (MenACWY-D or MenACWY-CRM) administered at 11 through 12 years of age is unlikely to provide continued protection against meningococcal serogroups A, C, Y, and W-135 in these individuals at 16 through 21 years of age.228 Duration of protective antibody after a booster dose of MenACWY vaccine given at 16 through 18 years of age is not known, but is expected to last at least through 21 years of age.228

Revaccination or 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.105 161 200 228 (See Dosage under Dosage and Administration.)

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune response in vaccinees.134

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.134 (See Storage under Stability.)

Do not administer meningococcal vaccine that has been mishandled or has not been stored at the recommended temperature.134

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.134

Specific Populations

Pregnancy

MenACWY-D: No adequate and well-controlled studies in pregnant women;108 animal studies have not revealed any evidence of harm to the fetus.108 Pregnancy registry at 800-822-2463.108 Instruct clinicians or vaccinees to report any exposure to the vaccine that occurs during pregnancy.108

MenACWY-CRM: No adequate and well-controlled studies in pregnant women;152 animal studies have not revealed any evidence of harm to the fetus.152 Pregnancy registry at 877-413-4759.152 Instruct clinicians or vaccinees to report any vaccine exposures that occur during pregnancy.152

ACIP and AAP state MenACWY vaccine (MenACWY-D or MenACWY-CRM) may be used during pregnancy if indicated in a woman at increased risk of meningococcal serogroups A, C, Y, and W-135 infection.105 228

ACIP states there is no evidence of risk to the fetus if inactivated vaccines are administered during pregnancy.134

Lactation

Not known whether antigens contained in MenACWY vaccine (MenACWY-D or MenACWY-CRM) are distributed into milk.108 152

Manufacturers state use MenACWY vaccine with caution in nursing women.108 152

ACIP states that administration of inactivated vaccines to a woman who is breast-feeding does not pose any safety concerns for the woman or her breast-fed infant.134

Pediatric Use

MenACWY-D (Menactra): Safety and efficacy not established in pediatric patients <9 months of age.108

MenACWY-CRM (Menveo): Safety and efficacy not established in pediatric patients <2 months of age.152

Apnea reported following IM administration of vaccines in some infants born prematurely.152 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.152

Geriatric Use

MenACWY-D (Menactra): Safety and efficacy not established in adults ≥56 years of age, including geriatric adults.108 However, ACIP recommends use of MenACWY vaccine in certain adults in this age group at increased risk.228 (See Preexposure Vaccination Against Meningococcal Infection in High-risk Groups under Uses.)

MenACWY-CRM (Menveo): Safety and efficacy not established in adults ≥56 years of age, including those ≥65 years of age.152 However, ACIP recommends use of MenACWY vaccine in certain adults in this age group at increased risk.228 (See Preexposure Vaccination Against Meningococcal Infection in High-risk Groups under Uses.)

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.108

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;152 injection site pain, headache, myalgia, malaise, nausea in adults and adolescents.152

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

Immunosuppressive Agents

Immune responses to vaccines, including MenACWY vaccine, may be reduced in individuals receiving immunosuppressive therapy.61 72 105 108 134 135 152 228

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.105 134 135

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.105

Vaccines

Although specific studies may not be available,152 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.90 105 108 134 228 (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.105 134 Each parenteral vaccine should be administered using separate syringes and different injection sites.105 134 228

Specific Drugs

Drug

Interaction

Comments

Diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTaP)

MenACWY-D: Limited data suggest interference with immune response to meningococcal antigens (immunologic blunting) if administered after DTaP in children 2 though 6 years of age228

MenACWY-D: In children 2 through 6 years of age, give MenACWY-D before, concurrently with (using separate syringes and different injection sites), or >6 months after DTaP;228 if inadvertently given ≤6 months after DTaP, MenACWY-D dose does not need to be repeated;228 if child is traveling to high-risk area or is at risk during a community outbreak, give MenACWY-D regardless of interval since DTaP228

MenACWY-CRM: May be given concurrently with (using separate syringes and different injection sites) or at any interval before or after DTaP228

HPV vaccine

MenACWY-D: Concurrent administration with Tdap (Adacel) and 9-valent HPV vaccine (9vHPV) at 3 different injection sites in adolescents did not interfere with antibody responses to any of the vaccine antigens;231 increased incidence of swelling at 9vHPV injection site compared with administration of the HPV vaccine alone231

MenACWY-CRM: Concurrent administration with 4-valent HPV vaccine (4vHPV; no longer available in US) and Tdap in adolescents 11 through 18 years of age did not interfere with immune responses to the meningococcal antigens;152 systemic adverse reactions were more frequent in those receiving MenACWY-CRM with 4vHPV and Tdap compared with MenACWY-CRM alone152

Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV], immune globulin sub-Q) or specific hyperimmune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])

No evidence that immune globulin preparations interfere with immune responses to inactivated vaccines134

MenACWY vaccine may be given concurrently with (using separate syringes and different injection sites) or at any interval before or after immune globulin or specific hyperimmune globulin134

Immunosuppressive agents (e.g., alkylating agents, antimetabolites, certain biologic response modifiers, corticosteroids, cytotoxic drugs, radiation)

Potential for decreased immune responses to vaccines61 72 105 108 134 152 228

Anti-B-cell antibodies (e.g., rituximab): Optimal time to administer vaccines after such treatment unclear135

Corticosteroids: May reduce immune responses to vaccines if given in greater than physiologic doses134

Chemotherapy or radiation: Give inactivated vaccines ≥2 weeks before and avoid during such therapy if possible;105 134 135 consider individuals unvaccinated if vaccinated during or ≤14 days after starting immunosuppressive therapy134 and revaccinate ≥3 months after such therapy discontinued if immune competence restored134 135

Anti-B-cell antibodies (e.g., rituximab): Give inactivated vaccines ≥2 weeks before or defer until ≥6 months after such treatment105 134 135

Certain biologic response modifiers (e.g., colony-stimulating factors, interleukins, tumor necrosis factor-α inhibitors): Give inactivated vaccines ≥2 weeks prior to initiation of such therapy;105 134 if inactivated vaccine indicated in patient with chronic inflammatory illness receiving maintenance therapy with a biologic response modifier, some experts state do not withhold the vaccine because of concern about exacerbation of inflammatory illness105 135

Corticosteroids: Some experts state give inactivated vaccines ≥2 weeks prior to initiation of immunosuppressive corticosteroid therapy if feasible,105 134 but may be given to those receiving long-term corticosteroid therapy for inflammatory or autoimmune disease;105 IDSA states, although it may be reasonable to delay inactivated vaccines in patients treated with high-dose corticosteroid therapy, recommendations for use of MenACWY vaccine in individuals receiving corticosteroid therapy (including high-dose corticosteroid therapy) generally are the same as those for other individuals135

Measles, mumps, and rubella vaccine (MMR)

MenACWY-D: Concurrent administration with MMR and VAR (or MMRV) and pneumococcal 7-valent conjugate vaccine (PCV7; no longer available in US) in infants 12 months of age did not affect antibody responses to MMR108 228

MenACWY-CRM: Concurrent administration with MMRV in infants 12 months of age did not affect antibody responses to MMRV;152 no increase in rate of solicited local or systemic adverse effects compared with administration of either vaccine alone152

Meningococcal group B (MenB) vaccine

MenACWY-D: Concurrent administration with MenB vaccine (MenB-FHbp; Trumenba) did not affect immune responses to meningococcal antigens in either vaccine236

MenACWY vaccine: May be given concurrently with MenB vaccine (MenB-4C; Bexsero or MenB-FHbp; Trumenba) using separate syringes and different injection sites134 200

Pneumococcal vaccine

PCV7 (no longer available in US): Concurrent administration with MenACWY-D at 12 months of age decreased antibody responses to 3 of the 7 pneumococcal serotypes compared with administration of PCV7 alone108 228

PCV7 (no longer available in US): Concurrent administration with MenACWY-CRM at 2, 4, 6, and 12 months of age resulted in possible interference with antibody responses to 2 of the pneumococcal vaccine serotypes at 1 month after third dose, but no evidence of interference with immune responses to any pneumococcal vaccine serotypes after fourth dose152

Pneumococcal 13-valent conjugate vaccine (PCV13): Manufacturer of PCV13 states data insufficient to assess concurrent administration with MenACWY vaccine in children and adolescents181

PCV13: To avoid possible interference with immune responses to PCV13 in infants and children with anatomic or functional asplenia, ACIP and AAP state do not give MenACWY-D concurrently with or within 4 weeks after PCV13;105 199 228 complete PCV13 vaccination series first and then give MenACWY-D ≥4 weeks later199 228

Pneumococcal 23-valent polysaccharide vaccine (PPSV23; Pneumovax 23): May be given concurrently with MenACWY vaccine (using separate syringes and different injection sites)105

Tetanus and diphtheria toxoids adsorbed (Td)

MenACWY-D: Concurrent administration with Td did not reduce antibody responses or increase adverse effects;108 228 although clinical importance unclear, antibody responses to some meningococcal antigens (i.e., serogroups C, Y, W-135) were higher when MenACWY-D given concurrently with Td compared with administration 1 month after Td108

Tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap)

MenACWY-D: Concurrent administration with Tdap (Boostrix) at different injection sites in adolescents 11–18 years of age did not interfere with antibody responses to the meningococcal, diphtheria, or tetanus antigens;193 although clinical importance unknown, immune response to pertactin pertussis antigen was lower when MenACWY-D and Tdap given concurrently193

MenACWY-D: Concurrent administration with Tdap (Adacel) and 9vHPV (Gardasil 9) at 3 different injection sites in adolescents 11 through 15 years of age did not interfere with antibody responses to any of the vaccine antigens231 233

MenACWY-CRM: Concurrent administration with Tdap (Boostrix) in adolescents and young adults 11–25 years of age did not affect immune responses to the diphtheria, tetanus, and meningococcal antigens;240 immune responses to the pertussis antigens were lower when MenACWY-CRM and Tdap given concurrently compared with Tdap alone240

MenACWY-CRM: Concurrent administration with Tdap alone or with HPV vaccine in adolescents 11 through 18 years of age did not affect immune responses to the meningococcal antigens;152 although clinical importance unclear, antibody responses to the pertussis antigens were lower compared with Tdap alone;152 systemic adverse reactions were more frequent in those receiving MenACWY-CRM with Tdap and 4vHPV compared with MenACWY-CRM alone152

Typhoid vaccine

Parenteral inactivated typhoid vaccine (Typhim Vi): Has been given concurrently with MenACWY-D without reduced antibody responses to either vaccine and without increased adverse effects108 228

Oral live typhoid vaccine (Vivotif): May be given concurrently with or at any interval before or after MenACWY vaccine134

Parenteral inactivated typhoid vaccine (Typhim Vi): May be given concurrently with (using separate syringes and different injection sites) or at any interval before or after MenACWY vaccine134

Varicella vaccine (VAR)

MenACWY-D: Concurrent administration with VAR and MMR (or MMRV) and PCV7 (no longer available in US) in infants 12 months of age did not affect antibody responses to VAR108

Yellow fever vaccine

Yellow fever vaccine has been administered concomitantly with previously available unconjugated meningococcal vaccine (MPSV4; Menomune) without evidence of reduced antibody responses to either vaccine and without any unusual adverse effects92

Stability

Storage

Parenteral

Solution, for IM Use

MenACWY-D (Menactra): 2–8°C.108 Do not freeze;108 if freezing occurs, discard vaccine.108 Protect from light.134

MenACWY-CRM (Menveo) lyophilized and liquid components: 2–8°C;152 protect from light.152 Do not freeze;152 discard if freezing occurs.152 Maintain at 2–8°C during transport.152 Use immediately after reconstitution, but may be stored at ≤25°C for up to 8 hours.152

Actions

  • MenACWY-D (Menactra) contains purified capsular polysaccharide antigens A, C, Y, and W-135 extracted from N. meningitidis and conjugated to diphtheria toxoid protein.108

  • MenACWY-CRM (Menveo) contains purified capsular polysaccharide antigens A, C, Y, and W-135 extracted from N. meningitidis and conjugated to diphtheria CRM197 protein.152

  • MenACWY vaccine (MenACWY-D or MenACWY-CRM) stimulates active immunity to infections caused by meningococcal serotypes represented in the vaccine (i.e., groups A, C, Y, W-135).105 108 152 228

  • Meningococcal vaccines stimulate active immunity to meningococcal infection by inducing production of specific IgG, IgM, and IgA antibodies.9 13 17 18 33 69 79 The relative importance of each type of antibody in providing initial and long-term bactericidal protection against N. meningitidis not determined.9 13 17 42 46 69 79 91

  • Minimum titer of anticapsular antibodies conferring protection against N. meningitidis serogroups A, C, Y, and W-135 not established;50 69 studies evaluating serogroup A and C meningococcal disease indicate that anticapsular antibody levels of ≥2 mcg/mL may be protective.50 69 71 Seroconversion usually defined as ≥twofold increase in serum anticapsular antibody titers50 or ≥fourfold increase in bactericidal antibody titers.8 50 59 60 In clinical studies, response to MenACWY vaccine was based on serum bactericidal antibodies measured using human complement (hSBA).108 152

  • Antigens contained in MenACWY vaccine are conjugated to protein carriers containing T-cell epitopes; these can elicit immune responses involving T cells and may provide longer-lasting immunity than that provided by previously available unconjugated meningococcal vaccine (MPSV4).106 108 134 152 228

  • Following primary immunization with a 4-dose regimen of MenACWY-CRM in infants (doses given at 2, 4, 6, and 12 months of age), proportion of infants with hSBA titers ≥1:8 at 1 month after fourth dose was 89, 95, 96, and 97% for meningococcal serogroups A, C, Y, and W-135, respectively.152

  • Immune response to single dose of MenACWY-CRM in individuals 2 through 55 years of age is similar to that reported with single dose of MenACWY-D.152

  • Reduced immune responses to meningococcal vaccines and lower antibody titers may occur in immunocompromised individuals (e.g., HIV-infected individuals, those with leukemia, lymphoma, or generalized malignancy, those receiving immunosuppressive therapy).108 134 228 (See Individuals with Altered Immunocompetence under Cautions.)

  • Duration of immunity against N. meningitidis serogroups A, C, Y, and W-135 after primary immunization with MenACWY vaccine not fully determined.105 108 152 228 (See Duration of Immunity under Cautions.)

  • In adolescents 11 through 18 years of age who previously received primary immunization with single dose of MenACWY-D or MenACWY-CRM, revaccination with MenACWY-CRM resulted in protective antibody titers in ≥99%.228 Data not available to date regarding revaccination with MenACWY-D following primary immunization with MenACWY-CRM.228

  • In individuals who previously received a dose of MenACWY-D, a booster dose of the vaccine given 4–6 years after prior dose (median age at time of booster dose was 17.1 years), >99% had hSBA titers ≥1:8 for all 4 meningococcal serogroups on day 28 after the booster dose.108 Prior to the booster dose, approximately 65, 44, 39, and 69% had hSBA titers ≥1:8 for meningococcal serogroups A, C, Y, and W-135, respectively.108

  • Principal mode of transmission of meningococcal infection is respiratory, most commonly through close personal contact with an individual with invasive meningococcal disease or direct exposure to nasopharyngeal secretions from an infected individual.14 62 79 105 115 166 228 However, vast majority of meningococcal disease cases in US occur in individuals with no known exposure who presumably acquire infection from an asymptomatic carrier.90 Invasive infection with N. meningitidis usually results in meningitis and/or meningococcemia.105 108 228 Onset of illness is usually sudden with signs and symptoms including fever, severe headache, stiff neck, nausea, vomiting, and rash.105 115 Meningococcal disease occurs most frequently in children <5 years of age and in adolescents and young adults 16 through 23 years of age.105 228 237

Advice to Patients

  • Prior to administration of MenACWY vaccine (MenACWY-D or MenACWY-CRM), provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative (VISs are available at [Web]).108 120 152

  • Advise patient and/or patient’s parent or guardian of the risks and benefits of vaccination with MenACWY vaccine.108 152

  • Advise patient and/or patient's parent or guardian of the importance of completing the full primary immunization series.152

  • Advise patient and/or patient’s parent or guardian that routine meningococcal vaccination is recommended in US for all adolescents 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.199 228 Also advise that meningococcal vaccine is recommended for certain individuals at increased risk for exposure to meningococcal disease (e.g., college students through 21 years of age, individuals with certain chronic medical conditions, international travelers, household and other close contacts of individuals with invasive meningococcal disease, health-care or laboratory workers, military personnel).199 200 228

  • Advise patient and/or patient’s parent or guardian that revaccination or booster doses of MenACWY vaccine may be needed in individuals who receive primary immunization and remain at prolonged increased risk for disease caused by meningococcal serogroups A, C, Y, and W-135.228

  • Advise patient and/or patient’s parent or guardian that MenACWY vaccine may not provide protection in all vaccinees.108

  • Importance of informing clinicians if any adverse reactions (including allergic reactions) occur with MenACWY vaccine.108 152 Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web].108 152

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.108 152

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.108 152

  • Importance of informing patients of other important precautionary information.108 152 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY-D)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IM use

4 mcg each of meningococcal A, C, Y, W-135 capsular polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier per 0.5 mL

Menactra

Sanofi Pasteur

Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY-CRM)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IM use

10 mcg of meningococcal A capsular polysaccharide and 5 mcg each of meningococcal C, Y, W-135 capsular oligosaccharides conjugated to 32.7–64.1 mcg of diphtheria CRM197 protein carrier per 0.5 mL

Menveo

GlaxoSmithKline

AHFS DI Essentials™. © Copyright 2019, Selected Revisions November 26, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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