Meningococcal Vaccine

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

Introduction

Inactivated (polysaccharide) vaccine.^{1 106 108} Meningococcal vaccine is commercially available in the US as meningococcal polysaccharide (serogroups A, C, Y and W-135) diphtheria toxoid conjugate vaccine (MCV4; Menactra)^{106 107 108} and meningococcal polysaccharide vaccine, groups A, C, Y and W-135 combined (MPSV4; Menomune).^{1 3 58 84 106} Both are quadrivalent vaccines containing A, C, Y, and W-135 capsular polysaccharide antigens extracted from Neisseria meningitidis and are used to stimulate active immunity to infection by these 4 N. meningitidis serotypes.^{1 3 4 58 84 106 107 108} Different meningococcal vaccines (e.g., monovalent serogroup C conjugate vaccines) may be available in other countries.^{3 16 37 41 51}

Uses for Meningococcal Vaccine

Prevention of Meningococcal Infection

Prevention of meningococcal infection in adults, adolescents, and children ≥2 years of age.^{1 4 106 108}

Meningococcal infection is an acute, life-threatening illness caused by Neisseria meningitidis and is transmitted person-to-person by the respiratory route.^{4 6 106 131} Annual US incidence of meningococcal disease is approximately 0.4–1.3 cases per 100,000 population resulting in an estimated 1000–3000 cases each year.¹³¹ Overall case fatality rate is 9–12%, even with anti-infective treatment;^{4 6 106 131} fatality rate may be as high as 40% in those with meningococcal sepsis (meningococcemia).¹³¹ Rate of invasive disease is twofold higher in young adults 17–20 years of age compared with the overall US population.¹³¹ Meningococcal infection may result in substantial morbidity; long-term sequelae (e.g., hearing loss, neurologic disability, digit or limb amputations) reported in 11–20% of patients.^{4 106 131} While N. meningitidis generally causes sporadic disease in the US, the frequency of localized outbreaks of meningococcal disease has increased in the US since 1991.^{106 131}

USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and American Academy of Family Physicians (AAFP) recommend that all children and adolescents be vaccinated against meningococcal infection at 11–12 years of age, with catch-up vaccination at 13 through 18 years of age for those not previously vaccinated.^{4 113 118}

ACIP, AAP, and AAFP also recommend vaccination of selected children 2 through 10 years of age and adults >18 years of age at high risk for meningococcal disease (See Preexposure Vaccination Against Meningococcal Infection in High-risk Groups under Uses) and for all college freshmen living in dormitories who have not previously received the vaccine.^{4 106 107 112 113 127} In addition, these experts state that any other unvaccinated individual desiring protection from meningococcal disease can be vaccinated.^{106 107 112 113 127}

Quadrivalent meningococcal vaccines may be used for outbreak control when such outbreaks are caused by vaccine-preventable N. meningitidis serogroups (i.e., A, C, Y, W-135).^{1 3 4 62 106}

Although safety and efficacy of quadrivalent meningococcal vaccines have not been established in children <2 years of age,¹ ACIP, AAP, and other clinicians state that use of MPSV4 (Menomune) may be considered when necessary to elicit short-term protection against serogroup A in children 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).^{3 4 6 36 71 90 91 106}

ACIP, AAP, and AAFP state that MCV4 (Menactra ) is preferred over MPSV4 (Menomune) for meningococcal vaccination in adults ≤55 years of age, adolescents, and children ≥2 years of age.^{106 107 112 113 118 119 120} MPSV4 (Menomune) should be used in adults ≥56 years of age and when MCV4 (Menactra ) is contraindicated or unavailable and is an acceptable alternative for short-term protection (i.e., 3–5 years) in other individuals.^{106 107 112 113 118 119 120}

Quadrivalent meningococcal vaccines will not prevent meningococcal infection caused by N. meningitidis serogroups not represented in the vaccines (e.g., serogroup B) and will not prevent infections caused by other pathogens.^{1 79 84 85 86 106 108}

Quadrivalent meningococcal vaccines are not indicated for treatment of meningococcal infections.^{1 108}

Although the meningococcal antigens in MCV4 (Menactra) are conjugated to diphtheria toxoid protein, this vaccine is not indicated for immunization against diphtheria.¹⁰⁸

Preexposure Vaccination Against Meningococcal Infection in High-risk Groups

Preexposure vaccination in previously unvaccinated adults, adolescents, and children ≥2 years of age who are or will be at high risk of exposure to N. meningitidis or at high risk of developing invasive meningococcal disease if they become infected with N. meningitidis.^{4 101 106 107 119}

Children 2 through 10 years of age at increased risk of meningococcal infection include those that travel to or reside in countries where meningococcal disease is hyperendemic or epidemic, those who have terminal complement deficiencies or anatomic or functional asplenia.^{4 113 119 127} Although ACIP, AAP, and AAFP do not currently recommend routine vaccination against meningococcal infection in this age group, preexposure vaccination with MCV4 (Menactra) is recommended for previously unvaccinated children 2 through 10 years of age at increased risk and for outbreak control.^{4 113 119 127}

Adolescents should receive primary immunization against meningococcal disease with MCV4 (Menactra) at 11–12 years of age, with catch-up vaccination at 13 through 18 years for those not previously vaccinated.^{4 113 118} Because the incidence of meningococcal disease increases during adolescence, previously unvaccinated individuals 11 through 18 years of age should receive MCV4 (Menactra) at the earliest possible health-care visit.¹¹⁸

College freshmen living in dormitories are at increased risk for meningococcal infection and previously unvaccinated individuals in this age group should receive primary immunization with MCV4 (Menactra) before entering college.^{4 118} Although the 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 (Menactra) also can be used in these undergraduates if they want to reduce their risk for meningococcal disease.^{106 107}

HIV-infected individuals are likely to be at increased risk for meningococcal disease, although the risk is less than that of invasive disease from Streptococcus pneumoniae infection.^{106 107 119 148} ACIP, AAP, CDC, National Institutes of Health (NIH), HIV Medicine Association of the IDSA, Pediatric Infectious Diseases Society, and other experts state that recommendations regarding use of meningococcal vaccine in HIV-infected adults, adolescents, and children are the same as those for individuals who are not infected with HIV.^{112 147 148} Therefore, HIV-infected adults, adolescents, and children 2 through 10 years of age at high risk for meningococcal disease because of other medical conditions (e.g., terminal complement deficiencies, anatomic or functional asplenia) or potential exposures (e.g., travel, college freshmen living in dormitories, military recruits) should be vaccinated.^{106 112 119 121 147 148} In addition, any other HIV-infected individuals desiring protection against meningococcal disease may receive primary immunization with meningococcal vaccine.^{106 107 119 148} HIV-infected individuals who previously received MPSV4 (Menomune) and continue to be at increased risk for meningococcal disease may be revaccinated with MCV4 (Menactra) if 3–5 years have elapsed since MPSV4 (Menomune) was administered.^{106 107 112 148} Consider that meningococcal vaccines may be less immunogenic in immunocompromised individuals.^{1 11 106 108} (See Individuals with Altered Immunocompetence under Cautions.)

Travelers to and residents of areas where N. meningitidis is hyperendemic or epidemic and where there is a recognized risk of exposure to meningococcal disease should be vaccinated against the disease.^{1 2 6 106 107} Incidence of meningococcal disease peaks regularly during the dry season (December to June) in areas of sub-Saharan Africa known as the “meningitis belt” extending from Mali to Ethiopia.^{1 2 3 6 35 43 44 45 106} N. meningitidis serogroup A predominates in the meningitis belt, but serogroups C, X, and W-135 also are reported.⁶ Therefore, ACIP, CDC, AAP, and other experts recommend primary immunization against meningococcal disease prior to travel to these high-risk areas for individuals ≥2 years of age, especially if prolonged contact is expected with local populations.^{2 6 75 101 106 107} Immunization against meningococcal disease is not a requirement for entry into any country, but officials in Saudi Arabia require that travelers to their country for the annual Hajj and Umrah pilgrimage have a certificate of vaccination against meningococcal disease.^{2 6 35 106} The most recent information concerning geographic areas for which vaccination against meningococcal disease is recommended can be obtained from international health clinics for travelers, state health departments, CDC at 877-394-8747, or CDC Travelers’ Health website ().^{6 106 107}

Household and other close contacts of individuals with invasive meningococcal disease or those with direct exposure to nasopharyngeal secretions from an infected individual should be immunized against meningococcal infection because of increased risk of exposure to N. meningitidis.^{1 3 4 14 58 62 79 106} Whenever a case of invasive meningococcal disease occurs, anti-infective prophylaxis (rifampin, ceftriaxone, or ciprofloxacin) is indicated for close contacts of the index case (e.g., household contacts, day-care center contacts, individuals exposed to the index case's oropharyngeal secretions)^{4 35 58 79 106} and is the principal means of preventing secondary cases.^{79 90 91 106} Because protective levels of anticapsular antibodies are not achieved until 7–14 days following vaccination, meningococcal vaccine cannot prevent early onset disease in close contacts and usually is not recommended following sporadic cases of invasive meningococcal disease.^{4 90 91 106} However, if cluster cases of invasive disease occur, public health officials may recommend use of meningococcal vaccine in close contacts as an adjunct to anti-infective prophylaxis.^{1 3 4 35 49 62 66 90 91 106} AAP states that adjunctive use of the vaccine may be indicated when an outbreak is caused by a serogroup represented in the vaccine.⁴

Individuals with terminal complement deficiency, properdin deficiency, or anatomic or functional asplenia are at increased risk for meningococcal disease, and ACIP, AAP, and other clinicians recommend that these individuals be vaccinated against the disease.^{4 11 35 53 67 85 87 88 106 107} Individuals with component deficiencies in the final common complement pathway (C3, C5-C9) are more susceptible to severe and/or recurrent N. meningitidis infection, particularly serogroup Y, than complement-sufficient individuals.^{3 34 67 79 80 81 82 83 85} Inherited properdin deficiency also is associated with an increased risk of contracting severe and/or recurrent meningococcal disease.^{26 79} Because individuals with functional or anatomic asplenia may not be able to effectively clear encapsulated bacteria from the bloodstream, they are at increased risk of severe meningococcal disease.^{3 35 66 68 87 88} Administer meningococcal vaccine at least 2 weeks before elective splenectomy, if possible.^{11 87 88} MCV4 (Menactra) is the preferred meningococcal vaccine for individuals 2 through 55 years of age at high risk for meningococcal disease;^{106 107 108} MPSV4 (Menomune) is an acceptable alternative in this age group if the conjugated vaccine is unavailable.¹⁰⁶

Health-care workers who have close contact with nasopharyngeal secretions from patients with invasive meningococcal disease and laboratory personnel who are routinely exposed to isolates of N. meningitidis are at increased risk of meningococcal infection and should be vaccinated against meningococcal disease.^{1 3 49 58 97}

Military recruits are at increased risk of meningococcal disease and should be vaccinated against the disease.¹⁰⁶ MCV4 (Menactra) is the preferred meningococcal vaccine in adults ≤55 years of age; MPSV4 (Menomune) is an acceptable alternative for adults in this age group if the conjugated vaccine is unavailable.¹⁰⁶

Meningococcal Vaccine Dosage and Administration

Administration

Administer MCV4 (Menactra) by IM injection; administer MPSV4 (Menomune) by sub-Q injection.^{1 4 11 108}

IM Administration

MCV4 (Menactra): Administer by IM injection.^{4 11 108}

Do not administer IV, intradermally, or sub-Q.¹⁰⁸

Do not dilute.¹⁰⁸ Do not mix with any other vaccine or solution.¹⁰⁸

IM injections preferably should be made into the deltoid muscle.¹⁰⁸ To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.^{11 149 150} Consider anatomic variability, especially in the deltoid, and use clinical judgement to avoid inadvertent underpenetration or overpenetration of muscle.^{149 150}

Generally, do not administer vaccine into buttock muscle in children because of potential for injection-associated injury to the sciatic nerve.¹¹

Avoid injection of vaccines into or near blood vessels.¹¹ Although some experts recommend that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) be performed to ensure that a blood vessel has not been entered, ACIP and AAP state this procedure is not required because large blood vessels are not present at recommended IM injection sites.¹¹

Since syncope may occur following vaccination, observe vaccinees for approximately 15 minutes after the dose.^{11 126} Syncope occurs most frequently in adolescents and young adults.^{11 126} If syncope occurs, observe patient until symptoms resolve.^{11 126}

Shake well before use.¹²⁵ The vaccine is a clear to slightly turbid liquid.¹⁰⁸ Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.¹²⁵

May be given simultaneously with other age-appropriate vaccines (e.g., human papillomavirus [HPV] vaccine) during the same health-care visit (using different syringes and different injection sites).^{1 4 11 58 90 91 106 108} (See Interactions.)

Sub-Q Administration

MPSV4 (Menomune ): Administer by sub-Q injection.^{1 4 11}

Do not administer IV, IM, or intradermally.¹

Administer sub-Q preferably into the upper-outer triceps area in children ≥2 years of age, adolescents, and adults, the upper-outer triceps area is preferred.¹¹

To ensure appropriate delivery, sub-Q injections should be made at a 45° angle using a 5/8-inch, 23- to 25-gauge needle.¹¹

Observe vaccinee for approximately 15 minutes following administration of the vaccine since syncope may occur.^{11 126}

May be given simultaneously with other age-appropriate vaccines (e.g., HPV vaccine) during the same health-care visit (using different syringes and different injection sites).^{1 4 11 58 90 91 106 108} (See Interactions.)

Reconstitution

To reconstitute, add volume of diluent specified on diluent vial to the single- or multiple-dose vial of lyophilized vaccine.¹ Use only the diluent supplied by the manufacturer.^{1 125}

Shake thoroughly until vaccine is completely dissolved.¹ Reconstituted vaccine is a clear, colorless liquid.¹

Diluent supplied with single-dose vials is sterile, preservative-free distilled water; diluent supplied with multiple-dose vials is sterile distilled water containing thimerosal as a preservative.¹ (See Thimerosal Precautions under Cautions.)

Use reconstituted single-dose vial within 30 minutes.^{1 4 125} Use reconstituted multiple-dose vial within 35 days.^{1 4 125} (See Storage under Stability.)

Dosage

Dosing schedule varies according to the individual’s age and immunization status and specific vaccine administered.^{1 108}

Pediatric Patients

Preexposure Vaccination Against Meningococcal Infection in High-risk Groups

Children 3 through 23 Months of Age† (MPSV4; Menomune)

Sub-Q

Although safety and efficacy not established,¹ ACIP states that children 3 through 18 months of age may receive 2 doses (0.5 mL) given 3 months apart and those 19 through 23 months may receive a single dose (0.5 mL) under certain circumstances if vaccination is considered necessary for short-term protection against serogroup A.¹⁰⁶ (See Prevention of Meningococcal Infection under Uses.) In this age group, immunologic response to other serogroups represented in the vaccine is poor.⁴

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

IM

Primary immunization consists of a single 0.5-mL dose.¹⁰⁸

ACIP, AAP, and AAFP state that MCV4 (Menactra) is preferred for children 2 through 10 years of age.^{107 113 119 120}

Duration of immunity not fully determined.^{3 4 106 107 108 119} Revaccination using MCV4 (Menactra) is recommended for those who are at prolonged increased risk for meningococcal disease.¹⁵¹ ACIP recommends that children who were previously vaccinated at 2–6 years of age and are at prolonged increased risk should be revaccinated with MCV4 (Menactra) 3 years later.¹⁵¹ Children who were previously vaccinated at ≥7 years of age and are at prolonged increased risk should be revaccinated with MCV4 (Menactra) 5 years later.¹⁵¹ If at continued increased risk, revaccinate with MCV4 (Menactra) every 5 years thereafter.¹⁵¹ (See Duration of Immunity under Cautions.)

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

Sub-Q

Primary immunization consists of a single 0.5-mL dose.¹

ACIP, AAP, and AAFP state that MCV4 (Menactra) is preferred for children in this age group at increased risk for meningococcal disease (see Preexposure Vaccination Against Meningococcal Infection in High-risk Groups under Uses);^{107 113 119 120} MPSV4 (Menomune) is an acceptable alternative for short-term protection (i.e., 3–5 years) and should be used when MCV4 (Menactra ) is contraindicated or unavailable.^{107 113 119 120}

Duration of immunity not fully determined.^{3 4 106 107 108} If MPSV4 (Menomune) was used for primary immunization, revaccination using MCV4 (Menactra) is recommended for those who are at prolonged increased risk for meningococcal disease.¹⁵¹ ACIP recommends that children who were previously vaccinated at 2–6 years of age and are at prolonged increased risk should be revaccinated with MCV4 (Menactra) 3 years later.¹⁵¹ Children who were previously vaccinated at ≥7 years of age and are at prolonged increased risk should be revaccinated with MCV4 (Menactra) 5 years later.¹⁵¹ If at continued increased risk, revaccinate with MCV4 (Menactra) every 5 years thereafter.¹⁵¹ (See Duration of Immunity under Cautions.)

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

IM

Primary immunization consists of a single 0.5-mL dose.¹⁰⁸

ACIP, AAP, and AAFP recommend routine primary immunization for all adolescents at 11–12 years of age, if not previously vaccinated.^{4 113 106 118} Catch-up vaccination recommended at 13 through 18 years of age for those not previously vaccinated.^{4 113 106 118}

ACIP, AAP, and AAFP state that MCV4 (Menactra) is preferred for adolescents 11 through 18 years of age.^{106 107 113 118 120}

Duration of immunity not fully determined.^{3 4 106 107 108 119} Revaccination using MCV4 (Menactra) is recommended for those who are at prolonged increased risk for meningococcal disease.¹⁵¹ ACIP recommends that those who were previously vaccinated at ≥7 years of age and are at prolonged increased risk should be revaccinated with MCV4 (Menactra) 5 years later.¹⁵¹ If at continued increased risk, revaccinate with MCV4 (Menactra) every 5 years thereafter.¹⁵¹ (See Duration of Immunity under Cautions.)

Because most students entering college will have received a dose of MCV4 (Menactra) within the preceding 4 years, ACIP does not currently recommend revaccination with MCV4 (Menactra) for college freshmen living in dormitories who previously received a dose of the vaccine.¹⁵¹

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

Sub-Q

Primary immunization consists of a single 0.5-mL dose.¹

ACIP, AAP, and AAFP recommend routine primary immunization for all adolescents at 11–12 years of age, if not previously vaccinated.^{4 113 106 118} Catch-up vaccination recommended at 13 through 18 years of age for those not previously vaccinated.^{4 113 106 118}

ACIP, AAP, and AAFP state that MCV4 (Menactra) is preferred for adolescents 11 through 18 years of age;^{106 107 113 118 120} MPSV4 (Menomune) is an acceptable alternative for short-term protection (i.e., 3–5 years) and should be used when MCV4 (Menactra ) is contraindicated or unavailable.^{106 107 113 118 120}

Duration of immunity not fully determined.^{3 4 106 107 108} If MPSV4 (Menomune) was used for primary immunization, revaccination using MCV4 (Menactra) is recommended for those who are at prolonged increased risk for meningococcal disease.¹⁵¹ ACIP recommends that those who were previously vaccinated at ≥7 years of age and are at prolonged increased risk should be revaccinated with MCV4 (Menactra) 5 years later.¹⁵¹ If at continued increased risk, revaccinate with MCV4 (Menactra) every 5 years thereafter.¹⁵¹ (See Duration of Immunity under Cautions.)

ACIP recommends that college freshmen living in dormitories who received MPSV4 (Menomune) ≥5 years earlier and have not previously received a dose of MCV4 (Menactra) should be revaccinated with MCV4 (Menactra).¹⁵¹

Adults

Preexposure Vaccination Against Meningococcal Infection in High-risk Groups

Adults 19 through 55 Years of Age (MCV4; Menactra)

IM

Primary immunization consists of a single 0.5-mL dose.¹⁰⁸

ACIP, AAP, and AAFP state that MCV4 (Menactra) is preferred for adults 19 through 55 years of age.^{106 107 112}

Duration of immunity not fully determined.^{3 4 106 107 108 119} ACIP recommends revaccination using MCV4 (Menactra) every 5 years for those who remain at continued increased risk for meningococcal disease.¹⁵¹ (See Duration of Immunity under Cautions.)

Adults ≥19 Years of Age (MPSV4; Menomune)

Sub-Q

Primary immunization consists of a single 0.5-mL dose.¹

ACIP, AAP, and AAFP state that MPSV4 (Menomune) is preferred for adults ≥56 years of age.^{106 107 112} Although MCV4 (Menactra) is preferred for adults 19 through 55 years of age,^{106 107 112} MPSV4 (Menomune) is an acceptable alternative for short-term protection (i.e., 3–5 years) and should be used in this age group when MCV4 (Menactra ) is contraindicated or unavailable.^{106 107 112}

Duration of immunity not fully determined.^{3 4 106 107 108 119} If MPSV4 (Menomune) was used for primary immunization, ACIP recommends revaccination using MCV4 (Menactra) every 5 years for those who remain at continued increased risk for meningococcal disease.¹⁵¹ (See Duration of Immunity under Cautions.)

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations. MPSV4 (Menomune) usually used in this age group; MCV4 (Menactra) not indicated in individuals ≥56 years of age.¹⁰⁸ (See Geriatric Use under Cautions.)

Cautions for Meningococcal Vaccine

Contraindications

• 
  

  MCV4 (Menactra): Hypersensitivity to any ingredient in the formulation, including diphtheria toxoid,^{11 108} Also contraindicated in individuals who have had a life-threatening reaction to any vaccine containing similar ingredients and in those with latex sensitivity.^{11 108} (See Hypersensitivity Reactions under Cautions.) Contraindicated in individuals with a history of Guillain-Barré syndrome (GBS).^{11 108} (See Guillain-Barré Syndrome [GBS] under Cautions.)

  
  


• 
  

  MPSV4 (Menomune): Hypersensitivity to any ingredient in the vaccine or diluent (e.g., thimerosal).^{1 11} (See Thimerosal Precautions under Cautions.) Also contraindicated in individuals with any acute illness.^{1 11}

  
  

Warnings/Precautions

Warnings

Guillain-Barré Syndrome (GBS)

There have been postmarketing reports of GBS occurring in temporal association with MCV4 (Menactra) vaccination.^{108 109 110 118 122 123 124} Although further study is needed to determine whether the vaccine is associated with an increased risk of GBS or increased risk of recurrence of GBS, the manufacturer states MCV4 (Menactra) is contraindicated in individuals with a history of GBS.¹⁰⁸ CDC and ACIP state that individuals with a history of GBS should not receive MCV4 (Menactra) unless they are at high risk for meningococcal disease.^{110 122 123}

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} It is 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

CDC and FDA currently are investigating the possible relationship between MCV4 (Menactra) and GBS.^{109 110 111 118 122 123 124} 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 of these cases occurred in vaccine recipients 11–19 years of age.^{110 122 123 124} Although the rate of GBS among recipients of MCV4 (Menactra) based on cases reported within 6 weeks of vaccination is similar to the number of expected cases in this age group over a 6-week period, the timing of the onset of neurologic symptoms relative to vaccination is of concern.¹²⁴

Because of the known risk for meningococcal exposure and the limited data indicating a small increased risk for GBS after MCV4 (Menactra) vaccination, CDC continues to recommend routine vaccination with MCV4 (Menactra) for adolescents, college freshmen living in dormitories, and other populations at increased risk for infection.^{123 124}

For individuals with a history of GBS, MPSV4 (Menomune) is an acceptable alternative for short-term protection (i.e., 3–5 years) against meningococcal disease.^{118 119}

Individuals considering vaccination with MCV4 (Menactra) or their parents or guardians should be informed of the ongoing investigation regarding the possible relationship between administration of MCV4 (Menactra) and the occurrence of GBS.^{110 122 124} Clinicians should remain alert to the possibility of vaccine-associated GBS and report any suspected cases to VAERS at 800-822-7967 or .^{109 110 111 123 124}

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., anaphylactic/anaphylactoid reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension, erythema multiforme) have been reported rarely in patients who received MCV4 (Menactra).^{108 146}

Hypersensitivity reactions (e.g., anaphylaxis) also have been reported with MPSV4 (Menomune), bivalent (serogroups A and C) meningococcal vaccines (not commercially available in the US), and monovalent (serogroup A) meningococcal vaccine (not commercially available in the US).^{22 73 106}

Take all known precautions to prevent adverse reactions, including a review of the patient’s history with respect to possible hypersensitivity to the vaccine, similar vaccines, or to latex.^{1 108}

Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs.^{1 108}

When MPSV4 (Menomune) is indicated in individuals with a history of sensitivity to thimerosal, use the single-dose vials reconstituted with the preservative-free diluent supplied by the manufacturer.¹ (See Thimerosal Precautions under Cautions.)

Latex Sensitivity

A packaging component (i.e., vial stopper) of MCV4 (Menactra) and MPSV4 (Menomune) contains dry natural rubber latex.^{1 108}

Some individuals may be hypersensitive to natural latex proteins.^{1 11 108} Take appropriate precautions if these preparations are administered to individuals with a history of latex sensitivity.^{1 11 108}

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.¹¹

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 has been reported in some individuals.^{129 132 137 139} These reactions usually manifest as local, delayed-type hypersensitivity reactions (e.g., erythema, swelling),^{11 129 132} 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