Meningococcal Vaccine

Class: Vaccines
ATC Class: J07AH01
VA Class: IM100
Brands: Menactra, MenHibrix (combination), Menomune, Menveo

Introduction

Inactivated (polysaccharide) vaccine.1 106 108 152 228 Commercially available in US as 2 types: conjugated (MCV4) and unconjugated (MPSV4) meningococcal polysaccharide vaccines.1 105 106 108 152 228 There are 2 different conjugated (MCV4) vaccines in US: 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 Unconjugated (MPSV4) vaccine available as meningococcal polysaccharide vaccine, groups A, C, Y and W-135 combined (MPSV4; Menomune).1 All 3 are quadrivalent vaccines containing A, C, Y, and W-135 capsular polysaccharide antigens extracted from Neisseria meningitidis.1 106 108 152 228 Fixed-combination vaccine containing 2 conjugated meningococcal capsular polysaccharide antigens (groups C and Y) with Haemophilus influenzae type b (Hib) tetanus toxoid conjugate vaccine (Hib-MenCY; MenHibrix) also available in US.227 Various other meningococcal vaccines (e.g., multicomponent serogroup B vaccine, monovalent serogroup C conjugate vaccines) may be available in other countries.16 37 41 51 106 228

Uses for Meningococcal Vaccine

Prevention of Meningococcal Infection

Prevention of meningococcal infection in adults, adolescents, children, and infants ≥9 months of age.1 105 106 108 152 153 154 157 164 166 199 200 228

Meningococcal infection is an acute, life-threatening illness caused by N. meningitidis; transmitted person to person by the respiratory route.6 105 106 166 228 Prior to 2000, annual US incidence of meningococcal disease was approximately 0.5–1.1 cases per 100,000 population resulting in an estimated 1400–2800 cases each year.166 Overall disease incidence has decreased in US since 2000, but peak incidence in individuals 18–21 years of age has persisted, even after routine vaccination of adolescents was initiated in 2005.153 166 During 2005–2011, estimated 800–1200 cases occurred annually in US.228 Overall case fatality rate is 9–15% (even with anti-infective treatment);105 106 166 228 fatality rate may be as high as 40% in those with meningococcemia.166 Meningococcal infection can result in substantial morbidity; long-term sequelae (e.g., hearing loss, neurologic disability, digit or limb amputations) reported in 11–20% of patients.105 106 166 228 While N. meningitidis generally causes sporadic disease in US, localized outbreaks of meningococcal disease do occur.106 166 228

USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend routine vaccination against meningococcal infection in all adolescents, preferably at 11 through 12 years of age, followed by a booster dose at 16 years of age.105 153 157 199 228 Catch-up vaccination recommended at 13 through 18 years of age for those not previously vaccinated;105 153 157 199 228 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 infection in selected infants, children, adolescents, and adults at high risk for the disease because of certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia) or because they will be traveling to or residing in areas with hyperendemic or epidemic meningococcal disease caused by serogroups represented in the vaccine.105 106 153 154 157 162 199 200 228 Also recommended in some other individuals at increased risk (e.g., HIV-infected individuals, certain health-care and laboratory personnel, military recruits).106 153 156 157 199 200 228 235 (See Preexposure Vaccination Against Meningococcal Infection in High-risk Groups under Uses.)

Meningococcal vaccine may be used as adjunct to chemoprophylaxis in household and other close contacts of individuals with invasive meningococcal disease105 106 228 235 when clusters or outbreaks are occurring and are caused by vaccine-preventable meningococcal serogroups (i.e., A, C, Y, W-135).62 105 106 107 154 199 228 (See Outbreak Control under Uses.)

MCV4 (Menactra, Menveo) preferred for primary and booster vaccination or revaccination against meningococcal infection in infants ≥9 months of age, children, adolescents, and adults 19 through 55 years of age.106 153 154 157 166 199 200 228 ACIP states MCV4 (Menactra, Menveo) also preferred in adults ≥56 years of age who previously received MCV4 if revaccination indicated or multiple doses anticipated (e.g., individuals at increased risk because of certain chronic medical conditions, laboratory personnel).228

ACIP and others state reserve use of MPSV4 (Menomune) for short-term protection (i.e., 3–5 years) in certain previously unvaccinated adults ≥56 years of age when a single dose of meningococcal vaccine is expected to be required (e.g., travelers, community outbreaks) and for use as an alternative in children ≥2 years of age, adolescents, and adults when MCV4 (Menactra, Menveo) is unavailable.106 166 228

Although routine vaccination against meningococcal disease not recommended in infants who are not at increased risk,105 162 ACIP, AAP, and others state that the fixed-combination vaccine Hib-MenCY (MenHibrix) may be used for primary immunization against Hib in infants 6 weeks through 18 months of age who are at increased risk for meningococcal disease because of certain chronic medical conditions or because they reside in communities with outbreaks of meningococcal serogroup C or Y.162 199 228 In addition, use of MPSV4 (Menomune) may be considered when necessary to elicit short-term protection against serogroup A in infants 3 through 23 months of age under certain circumstances (e.g., infant will be traveling to or residing in areas where N. meningitidis is hyperendemic or epidemic or for outbreak control).71 90 106

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

MCV4 (Menactra, Menveo) and MPSV4 (Menomune) provide protection only against N. meningitidis serogroups represented in the vaccines (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.1 105 106 108 152 166 228

Hib-MenCY (MenHibrix) contains only N. meningitidis serogroups C and Y; will not prevent meningococcal infection caused by other serogroups (e.g., serogroups A, B, W-135).162 228

Preexposure Vaccination Against Meningococcal Infection in High-risk Groups

Infants 6 weeks through 18 months of age who are receiving primary immunization against Hib infection and are at increased risk for invasive meningococcal infection because they have certain chronic medical conditions (e.g., persistent complement component deficiencies or anatomic or functional asplenia, including sickle cell disease) or reside in communities with outbreaks caused by meningococcal serogroup C or Y may receive Hib-MenCY (MenHibrix).162 199 228 Does not provide adequate protection for infants and children traveling to or residing in areas with high endemic rates of meningococcal disease since it does not provide protection against meningococcal serogroups A and W-135;162 199 228 unlikely to provide persistent protection against meningococcal infection until 11 through 12 years of age, the age of recommended routine adolescent meningococcal vaccination.162

Infants 9 through 23 months of age with certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia) 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 with MCV4 (Menactra).154 157 199 228 ACIP, AAP, and others recommend a 2-dose primary immunization series of MCV4 (Menactra);105 108 154 199 228 booster doses of MCV4 recommended for those who received primary immunization and remain at prolonged increased risk.105 154 157 228 If Hib-MenCY (MenHibrix) was used for primary immunization in this age group, ACIP states a dose of MCV4 (Menactra) not necessary until usually recommended first booster dose indicated (i.e., 3 years after completion of the primary immunization series), unless infant will be traveling to or residing in areas with high endemic rates of meningococcal disease.228 Routine vaccination against meningococcal infection not recommended in infants not at increased risk.105 162

Children 2 through 10 years of age with certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia) 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 with MCV4 (Menactra, Menveo).105 153 157 164 199 228 ACIP, AAP, and others recommend a 2-dose primary immunization series of MCV4 for most of these children at high risk (a single dose recommended for travelers);105 153 157 164 199 228 booster doses of MCV4 recommended for those who received primary immunization and remain at prolonged increased risk.105 153 157 164 228 Routine vaccination against meningococcal infection not recommended in children 2 through 10 years of age not at increased risk.105 127 164

Adolescents 11 through 18 years of age are at increased risk for meningococcal infection and should receive routine primary immunization against meningococcal disease with MCV4 (Menactra, Menveo).105 153 157 199 228 ACIP, AAP, and others recommend a dose of MCV4 (Menactra, Menveo) in all young adolescents at 11 through 12 years of age, followed by a booster dose of MCV4 (Menactra, Menveo) at 16 years of age.105 153 157 199 228 Catch-up vaccination recommended at first opportunity for all older adolescents 13 through 18 years not vaccinated at 11 through 12 years of age.105 153 157 199 228 If first dose given at 13 through 15 years of age, a booster dose of MCV4 recommended at 16 through 18 years of age;153 157 199 228 booster dose not needed if first dose given at ≥16 years of age.153 157 199 228

College freshmen through 21 years of age living in dormitories are at increased risk for meningococcal infection and should receive primary immunization with MCV4 (Menactra, Menveo) if they did not receive a dose at ≥16 years of age.200 228 Although risk for meningococcal disease for nonfreshmen college undergraduates is similar to that for the general population of similar age (i.e., 18–24 years), ACIP and AAP state that MCV4 also can be used in these undergraduates to reduce their risk for meningococcal disease.106 107

Individuals with persistent complement component deficiencies (e.g., C3, C5–C9, properdin, factor H, factor D) or anatomic or functional asplenia (e.g., sickle cell disease) are at increased risk for invasive meningococcal disease,53 67 85 105 106 107 153 154 164 228 and ACIP, AAP, and others recommend routine age-appropriate primary and booster immunization against the disease.105 106 107 153 154 164 199 200 228 Because immune response to a single dose may not be sufficient in individuals with these medical conditions, ACIP, AAP, and others recommend a 2-dose primary immunization series of MCV4 in these adults, adolescents, children, and infants ≥9 months of age;105 153 154 157 164 199 200 228 booster doses of MCV4 recommended for those who received primary immunization and remain at prolonged increased risk.105 153 154 157 164 200 228 If not previously vaccinated, administer meningococcal vaccine at least 14 days before elective splenectomy whenever possible.134

HIV-infected individuals are likely to be at increased risk for meningococcal disease.106 107 119 156 228 ACIP, AAP, CDC, NIH, HIV Medicine Association of the IDSA, Pediatric Infectious Diseases Society, and others recommend that HIV-infected adults, adolescents, children, and infants ≥9 months at high risk for meningococcal disease because of other chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia) or potential exposures (e.g., travel, college freshmen living in dormitories, military recruits) be vaccinated.106 119 153 154 155 156 157 164 200 228 Any other HIV-infected individuals desiring protection against meningococcal disease also may be vaccinated.106 107 156 ACIP and AAP recommend a 2-dose primary immunization series of MCV4 (Menactra, Menveo) in HIV-infected adolescents 11 through 18 years of age and adults 19 through 55 years of age;153 157 199 200 228 clinicians may also elect to use a 2-dose primary series of MCV4 (Menactra, Menveo) in HIV-infected children 2 through 10 years of age.157 228 HIV-infected individuals who previously received MCV4 (Menactra, Menveo) or MPSV4 (Menomune) and continue to be at increased risk for meningococcal disease should receive meningococcal vaccine every 5 years (preferably MCV4).105 153 157 228 Consider that meningococcal vaccines may be less immunogenic in immunocompromised individuals.1 106 108 134 152 228 (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 disease.200 228 235 ACIP and Healthcare Infection Control Practices Advisory Committee (HICPAC) state that routine immunization against meningococcal 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 disease106 228 and should be vaccinated against the disease.106 200 228

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 the disease.105 106 107 115 121 153 228 Incidence peaks regularly during dry season (December to June) in areas of sub-Saharan Africa known as the “meningitis belt” extending from Senegal and Guinea eastward to Ethiopia.43 44 45 106 115 121 228 N. meningitidis serogroup A predominates in meningitis belt, but serogroups C, X, and W-135 also reported.115 ACIP, AAP, CDC, and others recommend primary immunization against meningococcal disease prior to travel to these high-risk areas for individuals ≥9 months of age, especially those traveling to meningitis belt from December to June and those likely to have prolonged contact with local populations.75 101 106 107 115 121 153 154 157 199 228 ACIP, AAP, and others recommend a 2-dose primary immunization series of MCV4 before travel for infants 9 through 23 months of age;105 154 157 199 228 single dose before travel recommended for children ≥2 years of age, adolescents, and adults (preferably MCV4).105 153 157 164 228 In previously vaccinated, booster dose of MCV4 recommended if it has been ≥5 years since last dose of meningococcal vaccine.228 Hib-MenCY (MenHibrix) does not provide adequate protection for infants traveling to or residing in areas with high endemic rates of meningococcal disease since it does not provide protection against meningococcal serogroups A and W-135.162 228 Immunization against meningococcal disease not a requirement for entry into any country, but officials in Saudi Arabia require that travelers to their country for annual Hajj and Umrah pilgrimage have a certificate of vaccination against meningococcal disease.106 115 121 228 Most recent information concerning geographic areas for which vaccination against meningococcal disease is recommended available from international health clinics for travelers, state health departments, CDC at 877-394-8747, or CDC Travelers’ Health website ().106 107 115 228

Household and other close contacts of individuals with invasive meningococcal disease are at increased risk for meningococcal infection.14 62 79 105 106 228 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)79 105 106 228 and is principal means of preventing secondary cases.79 90 106 228 Because protective antibody levels not achieved until 7–14 days following vaccination, meningococcal vaccine cannot prevent early-onset disease in close contacts and usually not recommended following sporadic cases.90 105 106 However, if cluster cases occur, vaccination is a possible adjunct to chemoprophylaxis and may be recommended by public health officials for close contacts.49 62 66 90 105 106

Outbreak Control

If a suspected outbreak of meningococcal disease occurs in US and is caused by vaccine-preventable serogroups of N. meningitidis (i.e., groups A, C, Y, W-135), public health authorities will determine whether large-scale vaccination programs are indicated.62 105 106 107 199 228 Most meningococcal outbreaks in US caused by serogroups B, C, and Y; each serotype responsible for about one-third of cases.166 228

Whenever sporadic or cluster cases or outbreaks of meningococcal disease occur in US, chemoprophylaxis (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is principal means of preventing secondary cases in household and other close contacts.79 90 105 106

ACIP, AAP, and others state that consideration can be given to administering MPSV4 (Menomune) in infants as young as 3 months of age for short-term protection when an outbreak is known to involve meningococcal serogroup A.3 36 90 106 228 MCV4 (Menactra, Menveo), MPSV4 (Menomune), and Hib-MenCY (MenHibrix) not indicated for meningococcal serogroup B outbreaks since they do not stimulate immunity to serogroup B.1 3 48 79 84 85 86 106 108 152 166 228

Meningococcal Vaccine Dosage and Administration

Administration

MCV4 (Menactra, Menveo): Administer IM.108 152

MPSV4 (Menomune): Administer sub-Q.1

Hib-MenCY (MenHibrix): Administer IM.227

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination;134 152 227 may be accompanied by transient neurologic signs (e.g., visual disturbance, paresthesia, tonic-clonic limb movements).227 Occurs most frequently in adolescents and young adults.134 Have procedures in place to avoid falling injury and restore cerebral perfusion following syncope.134 227 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

May be given simultaneously with other age-appropriate vaccines.105 106 134 228 When multiple vaccines are administered during a single health-care visit, give each parenteral vaccine with a different syringe and at different injection site.134 228 Separate injection sites by at least 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 In infants and children 6 weeks to 2 years of age, anterolateral thigh is preferred;134 227 alternatively, deltoid muscle can be used in those 1 through 2 years of age if muscle mass is adequate.134 227 In adults, adolescents, and children ≥3 years of age, deltoid muscle is preferred.134 152

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; use clinical judgment to avoid inadvertent underpenetration or overpenetration of muscle.149 150

Avoid injection into gluteal area or into or near blood vessels or nerves.134 Generally do not administer vaccines into gluteal area or any area where there may be a major nerve trunk.134 If the gluteal muscle is chosen for infants <12 months of age because of special circumstances (e.g., physical obstruction of other sites), it is essential that clinician identify anatomic landmarks prior to injection.134

MCV4 (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; discard if it contains particulate matter, appears discolored, or cannot be resuspended with thorough agitation.108

Do not mix with any other vaccine.108

MCV4 (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; inject into vial containing lyophilized component.152 Invert vial; 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; 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

Hib-MenCY (MenHibrix)

Administer only by IM injection.227

Reconstitute single-dose vial of lyophilized vaccine by adding 0.6 mL of 0.9% sodium chloride diluent supplied by the manufacturer;227 shake well.227 Consult manufacturer’s labeling for specific information regarding reconstitution.227

Administer immediately after reconstitution.227

Do not mix with any other vaccine.227

Sub-Q Administration

MPSV4 (Menomune)

Administer only by sub-Q injection, preferably into the deltoid.1

To ensure appropriate delivery, make sub-Q injections at a 45° angle using a 5/8-inch, 23- to 25-gauge needle.134

Reconstitute single-dose vial of lyophilized vaccine by adding 0.6 mL of diluent supplied by the manufacturer (sterile, preservative-free distilled water).1

Reconstitute multiple-dose vial of lyophilized vaccine by adding 6 mL of diluent supplied by the manufacturer (sterile distilled water containing thimerosal as a preservative).1 (See Thimerosal Precautions under Cautions.)

Swirl vial until vaccine is completely dissolved.1 Reconstituted vaccine is a clear, colorless solution.1

Use single-dose vial immediately after reconstitution.1

Multiple-dose vial may be stored at 2–8°C after reconstitution; use within 35 days.1

Do not mix with any other vaccine.1

Dosage

Dosing schedule (i.e., number of primary and booster doses) and specific vaccine administered (MCV4 [Menactra, Menveo], MPSV4 [Menomune], Hib-MenCY [MenHibrix]) depend on individual’s age, immunization status, and risk factors.1 108 152 227 228 Follow age-appropriate recommendations for specific preparation used.1 108 152 227 228

ACIP, AAP, and others state that MCV4 (Menactra, Menveo) is preferred meningococcal vaccine for primary and booster immunization in infants and children 9 months through 10 years, adolescents 11 through 18 years, and adults 19 through 55 years of age.106 107 157 164 199 200 228 MPSV4 (Menomune) usually reserved for use in unvaccinated adults ≥56 years of age when single dose indicated and as an alternative in children ≥2 years of age, adolescents, and adults when MCV4 (Menactra, Menveo) unavailable.106 107 166 228 (See Uses.)

Limited data suggest the interchangeability of MCV4 (Menactra or Menveo).228 Although ACIP recommends using the same vaccine for all doses in the vaccination series whenever feasible,153 primary or booster doses should be administered when indicated, regardless of specific MCV4 vaccine (Menactra, Menveo) used for previous doses.153 164

Pediatric Patients

Preexposure Vaccination Against Meningococcal Infection in High-risk Groups
Infants 6 Weeks through 18 Months of Age (Hib-MenCY; MenHibrix)
IM

Each dose is 0.5 mL.227

Primary immunization in previously unvaccinated infants: Use a series of 4 doses.162 199 227 228 Give doses at 2, 4, 6, and 12 through 15 months of age.199 227 228

Initial dose usually given at 2 months of age, but may be given as early as 6 weeks of age.162 227 228 Fourth dose may be given as late as 18 months of age.162 227 228

If first dose given at ≥12 months of age, give a series of 2 doses at least 8 weeks apart.162 228

For those who remain at prolonged increased risk for meningococcal disease, ACIP recommends a dose of MCV4 3 years after completion of primary immunization series and every 5 years thereafter.228

Infants 9 through 23 Months of Age (MCV4; Menactra)
IM

Each dose is 0.5 mL.108

Primary immunization in those at high risk because of certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia) or travel to areas with hyperendemic or epidemic meningococcal disease: Give 2 doses 3 months apart (minimum 8 weeks apart).105 108 154 157 199 228 If necessary before travel, AAP states the doses can be given 2 months apart.105 157

For those who remain at prolonged increased risk for meningococcal disease, ACIP and AAP recommend a dose of MCV4 3 years after completion of primary immunization series and every 5 years thereafter.105 154 157 228

Infants 3 through 23 Months of Age (MPSV4; Menomune)
Sub-Q

Each dose is 0.5 mL.71

Short-term protection against serogroup A in infants 3 through 18 months of age: 2 doses given 3 months apart.106

Short-term protection against serogroup A in infants 19 through 23 months of age: Single dose.106

Children 2 through 10 Years of Age (MCV4; Menactra, Menveo)
IM

Each dose is 0.5 mL.108 152

Primary immunization in those at high 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 MCV4 administered 2 months apart.105 153 157 164 199 228

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 MCV4.105 153 157 164 228

For those who received primary immunization at 2 through 6 years of age and remain at prolonged increased risk for meningococcal disease, ACIP, AAP and others recommend a dose of MCV4 3 years after completion of primary immunization series and every 5 years thereafter.105 153 157 228 For those who received primary immunization at ≥7 years of age and remain at prolonged increased risk, give a dose of MCV4 every 5 years.105 153 157 228

Manufacturer states a single dose of Menactra can be used for primary immunization.108

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

Children 2 through 10 Years of Age (MPSV4; Menomune)
Sub-Q

Each dose is 0.5 mL.1

Manufacturer states a single dose can be used for primary immunization.1

For those who received primary immunization with MPSV4 at 2 through 6 years of age and remain at prolonged increased risk for meningococcal disease, ACIP, AAP, and others recommend a dose of meningococcal vaccine 3 years later and every 5 years thereafter (preferably MCV4).105 166 228 For those who received primary immunization at ≥7 years of age and remain at prolonged increased risk, give a dose of meningococcal vaccine every 5 years (preferably MCV4).105 166 228

Adolescents 11 through 18 Years of Age (MCV4; Menactra, Menveo)
IM

Each dose is 0.5 mL.108 152

Routine primary immunization in adolescents: ACIP, AAP, and others recommend a primary dose of MCV4 at 11 through 12 years of age, followed by a booster dose of MCV4 at 16 years of age.105 153 157 199 228

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.105 153 157 199 228 If first dose of MCV4 given at 13 through 15 years of age, give a booster dose at 16 through 18 years of age;153 157 199 228 booster dose not needed if first dose of MCV4 was given at ≥16 years of age.153 157 199 228

Primary immunization in adolescents 11 through 18 years of age at high 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 MCV4 administered 2 months apart.105 153 157 199 228 For those who remain at prolonged increased risk for meningococcal disease, ACIP and others recommend a dose of MCV4 every 5 years.166 200 228

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

Adolescents 11 through 18 Years of Age (MPSV4; Menomune)
Sub-Q

Each dose is 0.5 mL.1

Manufacturer states a single dose can be used for primary immunization.1

ACIP and others recommend that individuals who received primary immunization with MPSV4 and remain at prolonged increased risk for meningococcal disease should receive a dose of meningococcal vaccine every 5 years (preferably MCV4).166 200 228

Adults

Preexposure Vaccination Against Meningococcal Infection in High-risk Groups
Adults ≥19 Years of Age (MCV4; Menactra, Menveo)
IM

Each dose is 0.5 mL.108 152

Primary immunization in adults 19 through 55 years of age at high 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 MCV4 administered at least 2 months apart.153 200 228

Primary immunization in adults 19 through 55 years of age 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 MCV4.153 200 228

For those who remain at prolonged increased risk for meningococcal disease, ACIP and others recommend a dose of MCV4 every 5 years.153 200 228

Adults ≥56 years of age: ACIP recommends MCV4 when revaccination indicated or multiple doses anticipated in those who previously received MCV4 (Menactra, Menveo).228

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

Adults ≥19 Years of Age (MPSV4; Menomune)
Sub-Q

Each dose is 0.5 mL.1

Manufacturer states a single dose can be used for primary immunization.1

ACIP and others recommend that adults who received primary immunization with MPSV4 and remain at prolonged increased risk for meningococcal disease should receive a dose of meningococcal vaccine every 5 years (preferably MCV4).166 200 228

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.1 MPSV4 (Menomune) usually used in this age group.1 106 107 166 MCV4 (Menactra, Menveo) not labeled by FDA for use in individuals ≥56 years of age.108 152 (See Geriatric Use under Cautions.)

Cautions for Meningococcal Vaccine

Contraindications

  • MCV4 (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

  • MCV4 (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

  • MPSV4 (Menomune): Severe allergic reaction (e.g., anaphylaxis) to the vaccine or any vaccine component.1

  • Hib-MenCY (MenHibrix): Severe allergic reaction (e.g., anaphylaxis) to the vaccine, any vaccine component, or any vaccine containing meningococcal, Hib, or tetanus antigens.227

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

MCV4 (Menactra, Menveo): Hypersensitivity reactions (e.g., anaphylactic/anaphylactoid reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension, erythema multiforme) reported rarely.108 146 152

MPSV4 (Menomune): Hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria, pruritus, dyspnea, angioedema) reported;1 106 hypersensitivity reactions also reported with other unconjugated vaccines, including bivalent (serogroups A and C) meningococcal vaccines (not commercially available in US) and monovalent (serogroup A) meningococcal vaccine (not commercially available in US).22 73 106

Hib-MenCY (MenHibrix): Allergic reactions (e.g., anaphylactic/anaphylactoid reactions, angioedema) reported.227

Prior to administration, 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.1 108 152 227

Epinephrine and other appropriate agents and equipment should be readily available in case anaphylaxis or other serious allergic reaction occurs.1 108 152 227

Latex Sensitivity

Packaging components of MPSV4 (Menomune) and the diluent supplied by the manufacturer (i.e., vial stoppers) contain dry natural rubber latex.1

Some individuals may be hypersensitive to natural latex proteins.1 134 Take appropriate precautions if MPSV4 (Menomune) is administered to individuals with history of latex sensitivity.1 134

ACIP states that vaccines supplied in vials or syringes containing dry natural rubber or natural rubber latex may be administered to individuals with latex allergies other than anaphylactic allergies (e.g., history of contact allergy to latex gloves), but should not be used in those with a history of severe (anaphylactic) allergy to latex unless the benefits of vaccination outweigh the risk of a potential allergic reaction.134 Contact-type allergy is the most common type of latex sensitivity.134

Thimerosal Allergy

Following reconstitution, multiple-dose vials of MPSV4 (Menomune) contain thimerosal (25 mcg of mercury per 0.5-mL dose).1 129 (See Thimerosal Precautions under Cautions.)

Hypersensitivity reactions to thimerosal contained in vaccines reported in some individuals.129 132 137 139 These reactions usually manifest as local, delayed-type hypersensitivity reactions (e.g., erythema, swelling),129 132 134 but a generalized reaction manifested as pruritus and an erythematous, maculopapular rash on all 4 extremities has been reported rarely.139 Even when patch or intradermal tests for thimerosal sensitivity are positive, most individuals do not develop hypersensitivity reactions to thimerosal administered as a component of vaccines.132 134

ACIP states that a history of delayed-type hypersensitivity to thimerosal is not a contraindication to use of vaccines that contain thimerosal.134

Guillain-Barré Syndrome

Postmarketing reports of Guillain-Barré Syndrome (GBS) temporally associated with MCV4 (Menactra) vaccination.108 109 110 122 123 124

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

FDA and CDC investigating possible relationship between MCV4 (Menactra) and GBS.109 110 111 122 123 124 As of February 2008, the Vaccine Adverse Events Reporting System (VAERS) had received 26 confirmed case reports of GBS occurring within 6 weeks of MCV4 (Menactra) vaccination.124 Most cases occurred in vaccine recipients 11 through 19 years of age.110 122 123 124 Although rate of GBS among recipients of MCV4 (Menactra) based on cases reported within 6 weeks of vaccination is similar to number of expected cases in this age group over a 6-week period, timing of onset of neurologic symptoms relative to vaccination is of concern.124

GBS risk following administration of MCV4 (Menactra) evaluated retrospectively using data from >9 million individuals 11 through 18 years of age (15% received MCV4).108 Based on 72 chart-confirmed cases of GBS, no patients received MCV4 (Menactra) within 42 days of symptom onset.108 Additional 129 cases of potential GBS could not be confirmed or excluded using chart review.108 GBS risk estimated to range from 0–5 additional cases per 1 million vaccinees within 6 weeks following vaccination.108

Because of known risk for meningococcal exposure and limited data indicating an association between MCV4 (Menactra) vaccination and GBS, CDC continues to recommend routine vaccination with MCV4 for adolescents, college freshmen living in dormitories, and other populations at increased risk for infection.123 124

Manufacturer of MCV4 (Menactra) states that individuals with history of GBS may be at increased risk of GBS following administration of the vaccine;108 take into account benefits and risks of immunization before deciding to administer MCV4 (Menactra).108

Manufacturer of MCV4 (Menveo) states data not available to date to evaluate potential risk of GBS following administration of the vaccine.152

Manufacturer of Hib-MenCY (MenHibrix) states that, if GBS occurred within 6 weeks of receipt of a vaccine containing tetanus toxoid, base decision to administer a dose of any vaccine containing tetanus toxoid (including MenHibrix) on careful consideration of potential benefits and possible risks.227

After reviewing available safety data, ACIP concluded that benefits of meningococcal vaccination outweigh risks of GBS recurrence in individuals with 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 .109 110 111 123 124

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.106 134 228 Consider possibility that the immune response to the vaccine and efficacy may be reduced in these individuals.1 106 108 134 152 227 228

If possible, administer the vaccine prior to initiation of immunosuppressive therapy or defer until immunosuppressive therapy is discontinued.134 (See Specific Drugs under Interactions.)

HIV infection is not a contraindication for meningococcal vaccine.156

Safety and efficacy of Hib-MenCY (MenHibrix) not evaluated in immunosuppressed children.227

Concomitant Illness

A decision to administer or delay vaccination in an individual with a current or recent acute illness depends on the severity of symptoms and etiology of the illness.106 108 134

ACIP, AAP, and others state that minor acute illness, such as mild upper respiratory infection (with or without fever) or mild diarrhea, usually does not preclude vaccination.105 106 134 Generally defer vaccination of individuals with moderate or severe acute illness until they have recovered from the acute phase of the illness.1 105 106 134

Individuals with Bleeding Disorders

Manufacturer of MCV4 (Menveo) states the vaccine should not be used in individuals with any bleeding disorder or in those receiving anticoagulant therapy unless potential benefits outweigh risks associated with IM administration.152

ACIP states that vaccines may be given IM to individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient’s bleeding risk determines that the preparation can be administered 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 If patient is receiving antihemophilia therapy, administer the IM vaccine shortly after a scheduled dose of such therapy.134

Advise individual and/or their family about the risk of hematoma from IM injections.134

Thimerosal Precautions

Although there is no convincing evidence that the low concentrations of thimerosal (a mercury-containing preservative) contained in some vaccines is harmful to vaccine recipients,11 134 135 138 140 141 142 143 144 145 efforts to eliminate or reduce the thimerosal content in vaccines is recommended as a prudent measure to reduce mercury exposure in infants and children and part of an overall strategy to reduce mercury exposures from all sources, including food and drugs.102 103 104 133 134

It was suggested that thimerosal in vaccines theoretically could have adverse effects in vaccine recipients; however, there is no conclusive evidence that the low levels of thimerosal contained in vaccines cause harm in vaccine recipients.11 133 134 135 138 140 141 142 143 144 145 A link between thimerosal in vaccines and neurodevelopmental disorders in children (autism, attention deficit/hyperactivity disorder [ADHD], speech or language delay) possibly related to mercury neurotoxicity has been theorized; however, considerable evidence has accumulated that supports the absence of substantial risk for neurodevelopmental disorders or other harm resulting from exposure to thimerosal-containing vaccines.11 135 138 140 141 142 143 144 145 In 2004, the Immunization Safety Review Committee of the IOM examined the hypothesis that thimerosal-containing vaccines are causally associated with autism and concluded that the body of epidemiological evidence favors rejection of a causal relationship between these vaccines and autism.145

MPSV4 (Menomune): Following reconstitution with the diluent supplied by the manufacturer, multiple-dose vials contain thimerosal (25 mcg of mercury per 0.5-mL dose).1 129 Menomune supplied in single-dose vials and reconstituted with the preservative-free diluent supplied by the manufacturer does not contain thimerosal.1

MCV4 (Menactra, Menveo) and Hib-MenCY (MenHibrix): Do not contain thimerosal or any other preservative.108 152 227

Use of Combination Vaccines

When the combination vaccine containing meningococcal and Hib antigens (Hib-MenCY; MenHibrix) is used, consider cautions, precautions, and contraindications associated with each antigen.227 Do not use this fixed-combination vaccine concomitantly with any other Hib vaccine.228

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against meningococcal infection.1 105 108

Protective antibody levels may be achieved within 7–10 days after vaccination.115

MCV4 (Menactra, Menveo) and MPSV4 (Menomune) provide protection only against those meningococcal serogroups represented in the vaccines (i.e., groups A, C, Y, W-135).1 105 106 108 152 166 228 Will not prevent infection caused by other serogroups (e.g., serogroup B) and will not prevent infections caused by other pathogens.1 105 106 108 152 166 228

Hib-MenCY (MenHibrix) contains antigens representing only 2 meningococcal serogroups (i.e., groups C, Y) and will not prevent infection caused by other serogroups (e.g., serogroups A, B, W-135).162 228 Although Hib-MenCY (MenHibrix) contains Hib antigen conjugated to tetanus toxoid, this vaccine is not a substitute for routine immunization against tetanus.227

Extent and duration of the immunologic response to MPSV4 (Menomune) vary depending on the age of the recipient; the vaccine is less immunogenic in children <2 years of age than in older children and adults.9 24 28 31 42 46 62 84 85 86 106 228 Although children as young as 3 months of age may have an immunologic response to the serogroup A antigen contained in the vaccine, response to the other antigens is poor in children <2 years of age.105 228

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 the vaccines 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 MCV4 (Menactra, Menveo) or MPSV4 (Menomune) not fully determined.105 106 107 108 152 228

Because MPSV4 (Menomune) is an unconjugated vaccine, the vaccine antigens do not induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigens.106 107 134 228 Bactericidal antibodies formed in response to MPSV4 (Menomune) decline markedly during the first 2–3 years after vaccination.1 30 50 69 106 228 Although levels of anticapsular antibody after vaccination with MPSV4 (Menomune) are likely to persist in school-aged children and adults for ≥3 years,1 30 39 50 69 75 106 levels decline more rapidly in infants and children <5 years of age.1 3 29 70 71 228

Although MCV4 (Menactra, Menveo) is expected to provide a longer duration of protection than MPSV4 (Menomune),106 107 228 additional studies needed to determine relative duration of protection after primary immunization as well as duration of protection when individuals are revaccinated with conjugated or unconjugated vaccine after previously receiving the other vaccine type.106 107

Meningococcal antigens in MCV4 (Menactra, Menveo) are conjugated to protein carriers containing T-cell epitopes.106 107 108 152 228 This may result in improved primary response to the antigens and strong anamnestic response after reexposure to the antigens and may result in longer-lasting immunity than that provided by unconjugated vaccine.106 107 108 134 152 228

Adolescents who receive a single dose of MCV4 (Menactra, Menveo) at 11 through 12 years of age may have waning immunity 5 years after the dose and may have decreased protection against meningococcal disease by 16 through 21 years of age.153 228 Although duration of protective antibody after a booster dose of MCV4 given at 16 through 18 years of age is not known, it is expected to last through 21 years of age.153 228

Revaccination or booster doses of MCV4 (Menactra, Menveo) may be necessary in individuals who previously received MPSV4 (Menomune) or MCV4 (Menactra, Menveo) and continue to be at prolonged high risk for exposure to meningococcal infection.1 105 106 153 154 157 200 228 (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

Do not administer meningococcal vaccine that has been mishandled or has not been stored at the recommended temperature.134 (See Storage under Stability.) 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

MCV4 (Menactra): Category C.108 Pregnancy registry at 800-822-2463.108 Instruct clinicians or vaccinees to report any exposure to the vaccine that occurs during pregnancy.108

MCV4 (Menveo): Category B.152 Pregnancy registry at 877-311-8972.152 Instruct clinicians or vaccinees to report any vaccine exposures that occur during pregnancy.152

MPSV4 (Menomune): Category C.1

Hib-MenCY (MenHibrix): Category C.227 Not labeled by FDA for use in adolescents or adults.227

ACIP and AAP state MCV4 (Menactra, Menveo) or MPSV4 (Menomune) may be used during pregnancy if indicated in a woman at increased risk of meningococcal disease.105 228

Lactation

Not known whether antigens contained in meningococcal vaccine are distributed into milk.1 108 152 Because inactivated vaccines do not multiply within the body, ACIP states these vaccines should not pose any unusual problems for lactating women or their infants.134

MCV4 (Menactra, Menveo) and MPSV4 (Menomune): Manufacturers state use with caution in nursing women.1 108 152

Hib-MenCY (MenHibrix): Not labeled by FDA for use in adults.227

Pediatric Use

MCV4 (Menactra): Safety and efficacy not established in children <9 months of age.108

MCV4 (Menveo): Safety and efficacy not established in children <2 years of age.152

MPSV4 (Menomune): Safety and efficacy not established in children <2 years of age.1 Has been used in children 3–24 months of age for short-term protection against meningococcal serogroup A in infants traveling to an area hyperendemic or epidemic for meningococcal disease or for outbreak control.71 76 90 105 (See Prevention of Meningococcal Infection under Uses.)

Hib-MenCY (MenHibrix): Safety and efficacy not established in infants <6 weeks of age or in infants or children >18 months of age.227

Apnea reported following IM administration of vaccines in some infants born prematurely.227 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.227

Geriatric Use

MCV4 (Menactra): Safety and efficacy not established in adults ≥56 years of age, including geriatric adults.108 The ACIP recommends use in certain adults in this age group.228 (See Prevention of Meningococcal Vaccines under Uses.)

MCV4 (Menveo): Safety and efficacy not established in adults ≥56 years of age, including those ≥65 years of age.152 The ACIP recommends use in certain adults in this age group.228 (See Prevention of Meningococcal Vaccines under Uses.)

MPSV4 (Menomune): May be used in geriatric adults.1 Clinical studies did not include sufficient numbers of individuals ≥65 years of age to determine whether they respond differently than younger adults.1

Hib-MenCY (MenHibrix): Not labeled by FDA for use in adults, including geriatric adults.227

Common Adverse Effects

MCV4 (Menactra): Injection site reactions (e.g., pain, induration, erythema, swelling), headache, fatigue, malaise, arthralgia, diarrhea, anorexia, chills, fever, vomiting, rash.108

MCV4 (Menveo): 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

MPSV4 (Menomune): Injection site reactions (e.g., pain, erythema, induration, swelling), headache, malaise, chills, fever.1

Hib-MenCY (MenHibrix): Injection site reactions (e.g., pain, redness, swelling), systemic effects (e.g., fever, irritability, drowsiness, loss of appetite).227

Interactions for Meningococcal Vaccine

Other Vaccines

Although specific studies may not be available,1 152 simultaneous administration with other age-appropriate vaccines, including live virus vaccines, toxoids, or inactivated or recombinant vaccines, during the same healthcare visit is not expected to affect immunologic responses or adverse reactions to any of the preparations.1 90 105 106 108 134 228 Immunization with meningococcal vaccine can be integrated with immunization against diphtheria, tetanus, pertussis, Hib, hepatitis A, hepatitis B, human papillomavirus (HPV), influenza, measles, mumps, rubella, pneumococcal disease, poliomyelitis, and varicella.105 134 Each parenteral vaccine should be administered using a different syringe and different injection site.105 134 228

Specific Drugs

Drug

Interaction

Comments

Diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTaP)

MCV4 (Menactra): Limited data suggest interference with MCV4 immune response when administered after DTaP in children 2 though 6 years of age228

Hib-MenCY (MenHibrix): Concurrent administration with DTaP-HepB-IPV (Pediarix) and pneumococcal 7-valent conjugate vaccine (PCV7; Prevnar; no longer commercially available in US) in infants at 2, 4, and 6 months of age did not reduce antibody response to DTaP or the other antigens227

MCV4 (Menactra): In children 2 through 6 years of age, administer before, simultaneously with, or >6 months after DTaP;228 if MCV4 (Menactra) administered inadvertently within 6 months after DTaP, no need to repeat dose;228 if child is traveling to high-risk area or is at risk during a community outbreak, administer MCV4 (Menactra) regardless of interval since DTaP228

MCV4 (Menveo): May be administered simultaneously with or at any interval before or after DTaP228

Hib vaccine

Meningococcal and Hib vaccines may be administered simultaneously (using separate syringes and separate injection sites)105

Alternatively, fixed-combination vaccine (Hib-MenCY; MenHibrix) can be used when Hib vaccine is indicated in infants 6 weeks through 18 months of age at increased risk for meningococcal disease162 227 228

Hepatitis B (HepB) vaccine

Hib-MenCY (MenHibrix): Concurrent administration with DTaP-HepB-IPV (Pediarix) and PCV7 (Prevnar) in infants at 2, 4, and 6 months of age did not reduce antibody response to HepB or the other antigens227

Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV]) or specific immune 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 response to inactivated vaccines134

Meningococcal vaccine may be given simultaneously with or at any interval before or after immune globulin preparations134

Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)

Potential for decreased antibody response to vaccines1 61 72 106 108 134 152 227 228

If possible, avoid vaccination during chemotherapy or radiation134

Meningococcal vaccine may be administered at least 2 weeks before initiation of immunosuppressive therapy or deferred until ≥3 months after such therapy is discontinued134

Consider patients unvaccinated if they received meningococcal vaccine during or within 14 days before starting immunosuppressive therapy; revaccinate at least 3 months after such therapy is discontinued if immunocompetence restored134

Measles, mumps, and rubella vaccine (MMR)

MCV4 (Menactra): Concurrent administration with MMR and VAR (or MMRV) and PCV7 (Prevnar) in infants 12 months of age did not affect antibody responses to MMR108 228

Hib-MenCY (MenHibrix): Concurrent administration with MMR, VAR, and PCV7 (Prevnar) in infants 12 through 15 months of age did not interfere with immune response to MMR227

Pneumococcal vaccine

PCV7 (Prevnar): Simultaneous administration with MCV4 (Menactra) at 12 months of age decreased antibody responses to 3 of the 7 pneumococcal serotypes108 228

Hib-MenCY (MenHibrix): Concurrent administration with PCV7 (Prevnar) and DTaP-HepB-IPV (Pediarix) in infants at 2, 4, and 6 months of age did not reduce antibody response to PCV7 or the other antigens227

Pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13): Manufacturer states data insufficient to assess concomitant administration with MCV4 in children and adolescents167

PCV vaccination series in infants and children with anatomic or functional asplenia: To avoid possible interference with PCV immune response, ACIP and AAP recommend that MCV4 (Menactra) and PCV doses be administered at least 4 weeks apart;105 154 228 ACIP recommends that such children receive MCV4 (Menactra) vaccination beginning at 2 years of age after infant PCV series; if such children have not yet received all recommended infant doses of PCV, give MCV4 (Menactra) doses and any remaining PCV doses at least 4 weeks apart154 228

Hib-MenCY (MenHibrix): May be administered concomitantly with PCV13 (Prevnar 13) in infants 2 through 18 months of age228

Pneumococcal 23-valent polysaccharide vaccine (PPSV23; Pneumovax 23): May be administered simultaneously with MCV4 (Menactra, Menveo) or MPSV4 (Menomune) at different sites using separate syringes105

Tests to diagnose Hib disease

Hib-MenCY (MenHibrix): May interfere with interpretation of antigen tests used to diagnose Hib disease; administration of Hib vaccine results in antigenuria227

Hib-MenCY (MenHibrix): Urine antigen detection may not have diagnostic value in evaluating suspected Hib disease in children within 1–2 weeks following administration of the vaccine227

Antigen testing of urine and serum specimens no longer recommended for diagnosis of Hib infection105 166

Tetanus and diphtheria toxoids adsorbed (Td)

MCV4 (Menactra): Concurrent administration with Td did not reduce antibody responses or increase adverse effects;106 107 108 228 although clinical importance unclear, antibody responses to diphtheria and certain meningococcal antigens were higher when Menactra was given concurrently with Td compared with administration 1 month after Td106 107 108 228

MCV4 (Menactra, Menveo) or MPSV4 (Menomune): May be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after Td108 128 134

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

MCV4 (Menveo): Concurrent administration with Tdap (Boostrix) alone or with HPV vaccine (HPV4; Gardasil) in adolescents 11 through 18 years of age did not interfere with MCV4 immune response;152 228 although clinical importance unclear, antibody response to some pertussis antigens was decreased;152 228 systemic adverse reactions were more frequent in those receiving MCV4 with Tdap and HPV4 compared with those receiving MCV4 alone152

MCV4 (Menactra, Menveo): No evidence of interference with MCV4 immune response when administered following Tdap228

Tdap may be administered simultaneously with MCV4 (using different syringes and different injection sites);116 117 134 228 if this is not feasible, administer the vaccines at least 1 month apart116

Typhoid vaccine

Oral live typhoid vaccine (Vivotif): Data not available regarding simultaneous administration with meningococcal vaccines130

Parenteral inactivated typhoid vaccine (Typhim Vi): Has been administered concomitantly with MCV4 (Menactra)106 108 228 or MPSV4 (Menomune)92 without reduced antibody response or increased adverse effects92 106 108 228

Oral live typhoid vaccine (Vivotif): May be administered simultaneously with or at any interval before or after MCV4 (Menactra, Menveo) or MPSV4 (Menomune)134

Parenteral inactivated typhoid vaccine (Typhim Vi): May be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after MCV4 (Menactra, Menveo) or MPSV4 (Menomune)134

Varicella vaccine (VAR)

MCV4 (Menactra): Concurrent administration with VAR and MMR (or MMRV) and pneumococcal conjugate vaccine (PCV7; Prevnar) in infants 12 months of age did not affect VAR antibody responses108

Hib-MenCY (MenHibrix): Concurrent administration with VAR, MMR, and PCV7 (Prevnar) in infants 12 through 15 months of age did not interfere with immune response to VAR227

Yellow fever vaccine

MPSV4 (Menomune): Concomitant administration with yellow fever vaccine did not reduce antibody response or increase adverse effects92

Stability

Storage

Parenteral

Solution, for IM Use

MCV4 (Menactra): 2–8°C.108 Do not freeze;108 if freezing occurs, discard vaccine.108 Protect from light.134

MCV4 (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

Hib-MenCY (MenHibrix) lyophilized vaccine: 2–8°C;227 protect from light.227 Store 0.9% sodium chloride diluent supplied by manufacturer at 2–25°C;227 do not freeze; discard if freezing occurs.227 Use immediately after reconstitution.227 Discard reconstituted vaccine if frozen.227

For Injection, for Sub-Q Use

MPSV4 (Menomune) lyophilized vaccine and diluent provided by manufacturer: 2–8°C;1 do not freeze.1

Use single-dose vials immediately after reconstitution.1

Store multiple-dose vials at 2–8°C after reconstitution;1 134 discard if not used within 35 days.1 Diluent supplied with multiple-dose vials contains thimerosal as a preservative.1 (See Thimerosal Precautions under Cautions.)

Actions

  • MCV4 (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

  • MCV4 (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

  • MPSV4 (Menomune) contains purified capsular polysaccharide antigens A, C, Y, and W-135 isolated from N. meningitidis.1 84 The antigens are unconjugated.1

  • Hib-MenCY (MenHibrix) contains meningococcal groups C and Y and Hib antigens individually conjugated to tetanus toxoid.227

  • 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

  • Unconjugated antigens contained in MPSV4 (Menomune) cannot induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigens since polysaccharide antigens alone are T-cell independent.106 107 108 134 228

  • Antigens contained in MCV4 (Menactra, Menveo) 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 MPSV4 (Menomune).106 107 108 134 152 228

  • Extent and duration of immunologic response to MPSV4 (Menomune) vary depending on age of the recipient; the vaccine is less immunogenic in children <2 years of age than in older children and adults.9 24 28 31 42 46 62 84 85 86 228

  • MCV4 (Menactra) is at least as immunogenic as the unconjugated meningococcal vaccine (MPSV4, Menomune) in individuals 2 through 55 years of age.106 107 108 114

  • Immune response to single dose of MCV4 (Menveo) in individuals 2 through 55 years of age is similar to that reported with single dose of MCV4 (Menactra).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).1 106 108 134 228

  • Protective antibody levels may be achieved within 7–10 days after a dose of MCV4 (Menactra) or MPSV4 (Menomune).115

  • Duration of immunity after primary immunization with MCV4 (Menactra, Menveo) or MPSV4 (Menomune) not fully determined.105 106 107 108 152 228 (See Duration of Immunity under Cautions.)

  • In adolescents 11 through 18 years of age who previously received primary immunization with single dose of MCV4 (Menactra) or MCV4 (Menveo), revaccination with MCV4 (Menveo) resulted in protective antibody titers in ≥99%.228 Data not available to date regarding revaccination with MCV4 (Menactra) following primary immunization with MCV4 (Menveo).228

  • 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.1 14 62 79 105 106 115 228 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.1 105 106 108 228 Onset of illness is usually sudden with signs and symptoms including fever, severe headache, stiff neck, nausea, vomiting, and rash.105 115 Invasive meningococcal disease occurs most frequently in children <5 years of age and in adolescents and young adults 16 through 21 years of age.105 228

  • Minimum titer of anticapsular antibodies conferring protection against N. meningitidis serogroups A, C, Y, and W-135 not established;1 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 is defined as ≥2-fold increase in serum anticapsular antibody titers1 50 or ≥4-fold increase in bactericidal antibody titers.8 50 59 60

Advice to Patients

  • Prior to administration of the vaccine dose, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative (VISs are available at ).1 108 120 152 227

  • Advise patient and/or patient’s parent or guardian of the risks and benefits of vaccination with meningococcal vaccine.1 108 120 152 227

  • 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.120 199 228 Also advise that meningococcal vaccine is recommended for individuals at high risk for exposure to meningococcal disease (e.g., college students, individuals with certain chronic medical conditions, international travelers, household contacts, health-care or laboratory workers).120 199 200 228

  • Advise patient and/or patient’s parent or guardian that revaccination or booster doses may be needed in individuals who receive primary immunization against meningococcal infection and remain at prolonged increased risk for exposure to the disease.119 228

  • Advise patient and/or patient’s parent or guardian that meningococcal vaccine may not provide protection in all vaccinees.1 108

  • Advise patient and/or patient’s parent or guardian that fainting (sometimes resulting in falling with injury) can occur following vaccination, especially in adolescents and young adults; patient should sit or lie down during and for 15 minutes after vaccine administration.120 134

  • Importance of informing clinicians of a history of allergic reactions to meningococcal vaccine, any vaccine component (e.g., diphtheria CRM197, diphtheria toxoid, tetanus toxoid), or packaging component (e.g., latex).1 108 152 227

  • Importance of informing clinicians if any adverse reactions (including allergic reactions) occur with meningococcal vaccine.1 108 120 152 227 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 .1 108 120 152 227

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1 108 152 227

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 108 152

  • Importance of informing patients of other important precautionary information.1 108 152 227 (See Cautions.)

Preparations

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

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MCV4; 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 (MCV4; 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

Novartis

Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined (MPSV4)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for subcutaneous use

50 mcg each of meningococcal A, C, Y, W-135 capsular polysaccharides per 0.5 mL

Menomune-A/C/Y/W-135

Sanofi Pasteur

Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (Hib-MenCY)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IM use

5 mcg of meningococcal C capsular polysaccharide conjugated to approximately 5 mcg of tetanus toxoid protein carrier, 5 mcg of meningococcal Y capsular polysaccharide conjugated to approximately 6.5 mcg of tetanus toxoid protein carrier, and 2.5 mcg of Haemophilus b capsular polysaccharide conjugated to approximately 6.25 mcg of tetanus toxoid protein carrier per 0.5 mL

MenHibrix

GlaxoSmithKline

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions June 13, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

References

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