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    Meningococcal Vaccines, All Types

    DEA CLASS

    Rx

    DESCRIPTION

    Conjugate vaccine against Neisseria meningitidis serogroups A, C, Y, and W-135
    Used for immunization against invasive meningococcal disease
    Routine vaccination recommended for adolescents 11 to 18 years of age, preferably with 1 dose at age 11 or 12 years, and a booster dose at 16 years; booster doses may be indicated for individuals who remain at continued risk

    COMMON BRAND NAMES

    Menactra, Menveo

    HOW SUPPLIED

    Menactra/Menveo Intramuscular Inj Sol: 0.5mL, 10-5-5-5mcg
    Menveo Intramuscular Inj Pwd F/Sol: 0.5mL, 10-5-5-5mcg

    DOSAGE & INDICATIONS

    For meningococcal infection prophylaxis due to Neisseria meningitidis serogroups A, C, W, and Y.
    For booster dosing or revaccination of patients who remain at increased risk for meningococcal infection.
    Intramuscular dosage (Menactra, Menveo, and MenQuadfi)
    Adults

    0.5 mL IM. For continued protection of persons at high risk for meningococcal disease, ACIP recommends that a booster dose should be given 5 years after primary immunization and repeated every 5 years thereafter.[53760] The FDA-approved product labeling recommends that a single booster dose may be given if at least 4 years have elapsed since the prior dose and the risk of infection continues.[30775] [39161]

    Children and Adolescents who received the primary series after their 7th birthday

    0.5 mL IM. Timing of booster dose is dependent on when the primary series was completed and the indication. For routine immunization, a booster dose at age 16 years is recommended if the primary dose was given at age 11 or 12 years. If the primary dose was given at age 13 to 15 years, give a booster dose at age 16 to 18 years. No booster dose is needed if the primary dose was given on or after age 16 years. For continued protection of persons at high risk for meningococcal disease, ACIP recommends that a booster dose should be given 5 years after primary immunization and repeated every 5 years thereafter.[53760] The FDA-approved product labeling recommends that a single booster dose may be given in adolescents 15 years and older if at least 4 years have elapsed since the prior dose and the risk of infection continues.[30775] [39161]

    Children who received the primary series before the 7th birthday†

    0.5 mL IM. Give the first booster dose 3 years after the primary series and then subsequent doses every 5 years.[53760]

    Intramuscular dosage (Menveo only)
    Adults 18 to 55 years

    0.5 mL IM as a single dose. ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.

    Children and Adolescents 2 to 17 years

    0.5 mL IM as a single dose. For children age 2 to 5 years at continued high risk of meningococcal disease, a second dose may be administered 2 months after the first dose.[39161] ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

    Infants and Children 7 to 23 months

    0.5 mL IM. Give as a 2-dose series with the second dose given during the second year of life and at least 3 months after the first dose.[39161] [53026]

    Infants 2 to 6 months

    0.5 mL IM. Give as a 4-dose series with doses given at 2, 4, 6, and 12 months of age.

    Intramuscular dosage (Menactra only)
    Adults 18 to 55 years

    0.5 mL IM as a single dose.[30775] ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

    Children and Adolescents 2 to 17 years

    0.5 mL IM as a single dose.[30775] ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

    Infants and Children 9 to 23 months

    0.5 mL IM as a 2-dose series with doses given 3 months apart.[30775]

    Intramuscular dosage (MenQuadfi only)
    Adults

    0.5 mL IM as a single dose. ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

    Children and Adolescents 2 to 17 years

    0.5 mL IM as a single dose. ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

    MAXIMUM DOSAGE

    Adults

    older than 56 years: 0.5 mL IM of MenQuadfi; safety and efficacy of Menactra or Menveo have not been established.
    55 years or younger: 0.5 mL IM.

    Geriatric

    0.5 mL IM of MenQuadfi; safety and efficacy of Menactra or Menveo have not been established.

    Adolescents

    0.5 mL IM.

    Children

    Children 2 to 11 years: 0.5 mL IM.
    Children 1 year: 0.5 mL IM of Menactra or Menveo; safety and efficacy of MenQuadfi have not been established.

    Infants

    9 months and older: 0.5 mL IM of Menactra or Menveo; safety and efficacy of MenQuadfi have not been established.
    2 to 8 months: 0.5 mL IM of Menveo; safety and efficacy of Menactra and MenQuadfi have not been established.
    younger than 2 months: Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

     
    NOTE: According to U.S. federal laws, the health care provider must record in the patient's permanent record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine.
    Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients and should have immediate availability of epinephrine 1 mg/mL injection and other agents used in the treatment of severe anaphylaxis.
    Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
    If a meningococcal vaccine has been previously given, question the patient, parent, or guardian about any symptoms or signs of an adverse reaction.
    Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1-800-822-7967. Also, report an adverse event to the manufacturer by calling 1-800-822-2463 (Menactra) or 1-877-683-4732 (Menveo). Depending on the adverse reaction, a subsequent dose may be contraindicated.

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Menactra solution in the vial or syringe should be clear to slightly turbid. Menveo is a clear, colorless solution that is free from visible foreign particles. If discoloration or visible particulate matter are present, discard the vial or syringe.
    Do not administer fractional doses (i.e., doses less than 0.5 mL).
    When Daptacel and Menactra are to be given together for children 4 through 6 years, the two vaccines should be administered concomitantly or Menactra should be administered prior to Daptacel. Clinical trials found a reduced meningococcal antibody response when Menactra was administered one month after Daptacel.
    Do not mix with any other vaccine or product in the same syringe.

    Intramuscular Administration

    Reconstitution (Menveo only):
    Using a graduated syringe, withdraw the entire contents of the vial of MenCYW-135 liquid conjugate component and inject into the MenA lyophilized conjugate component vial. Invert and shake the reconstituted vial until the vaccine is dissolved. Withdraw 0.5 mL of reconstituted product for the dose.
    Storage of reconstituted vaccine: If possible, administer immediately after reconstitution; however, reconstituted Menveo may be held for up to 8 hours at 36 degrees F to 77 degrees F (2 degrees C to 25 degrees C). Do not freeze. Discard reconstituted vaccine if it has been frozen or not used within 8 hours.[39161]
     
    Intramuscular injection (Menactra and Menveo):
    Clean skin over the injection site with a suitable cleansing agent before administration.
    The preferred injection site is the anterolateral thigh in infants or the deltoid muscle of the upper arm for children, adolescents, and adults. Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk. Also, do not inject into an area that has been or will be used for another injection. A separate injection site is needed.
    Carefully observe patients for approximately 15 minutes after administration as syncope may occur.[30775] [39161]

    STORAGE

    Menactra:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Do not use if product has been frozen
    - Store between 35 to 46 degrees F
    Menveo:
    - Do not freeze
    - Do not use if product has been frozen
    - Protect from light
    - Store between 36 to 46 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Use of a meningococcal conjugate vaccine is contraindicated in patients with a previous allergic reaction to the vaccine. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the vaccine. Prior to the administration of the vaccine, the health care personnel should inform the patient, parent, guardian, or responsible adult of the benefits and risks to the patient. This should include the provision of the vaccine information statement from the manufacturer. The patient or responsible adult should report any adverse reaction following vaccine administration to the health care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. This includes, but is not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 800—822—7967.

    Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia, vitamin K deficiency

    Meningococcal conjugate vaccines are only for intramuscular (IM) administration. These vaccines may not be appropriate for patients with conditions that increase the risk of bleeding such as thrombocytopenia, bleeding disorders (e.g., hemophilia), coagulopathy, vitamin K deficiency, or for those receiving anticoagulant therapy; caution and appropriate precautions to minimize the risk of bleeding or hematoma formation are advised. The meningococcal polysaccharide vaccine (Menomune) may be an alternative option to consider, as it is indicated for subcutaneous administration.

    Fever, infection

    The decision to administer or to delay vaccination with meningococcal conjugate vaccine because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices has recommended that vaccinations be delayed during the course of a moderate or severe acute febrile illness. All vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness.

    Agammaglobulinemia, chemotherapy, human immunodeficiency virus (HIV) infection, hypogammaglobulinemia, immunosuppression, neoplastic disease, radiation therapy, severe combined immunodeficiency (SCID)

    Patients with significant immunosuppression may not have an adequate antibody response to meningococcal conjugate vaccine. Immunosuppressed persons may include patients with severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to generalized neoplastic disease; complement deficiencies; an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses); or patients receiving treatment that inhibits terminal complement activation (e.g. eculizumab). Patients with certain complement deficiencies and those receiving treatment that inhibits terminal complement activation are at an increased risk for disease cased by N meningitidis, even if they develop antibodies after vaccination. Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Patients vaccinated with meningococcal vaccine within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. In addition, evidence suggests that persons with human immunodeficiency virus (HIV) infection do not respond optimally to a single dose. According to the Advisory Committee on Immunization Practices (ACIP), individuals with HIV infection, functional/anatomical asplenia, or persistent complement deficiencies (i.e., C3, C5 to C9, properdin, factor D or factor H) require a 2-dose primary series administered 8 to 12 weeks apart.

    Pregnancy

    No adequate and well controlled studies have been conducted in pregnant women and the ability of the meningococcal conjugate vaccine to cause fetal harm or affect the reproductive system is unknown. An analysis of 5,065 women enrolled in clinical studies revealed 37 pregnancies among the 3,952 Menveo recipients and 6 pregnancies in the 1,113 patients treated with Menactra. A follow-up of these women found 7 spontaneous abortions and no congenital abnormalities in the Menveo group and no spontaneous abortions and 1 congenital abnormality (hydrocephalus) in the Menactra group. A pregnancy registry spanning from 2005 to 2016 included 222 reports of Menactra exposure for 30 days before or at any time during pregnancy. Out of the 87 available pregnancy outcomes, 2 major birth defects and 6 miscarriages were reported. The manufacturers recommend use during pregnancy only if clearly needed; however according to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated vaccines to pregnant women does not adversely affect the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. Instruct women who become pregnant at the time of vaccination to report the pregnancy to their health care professional. Health care professionals are encouraged to enroll exposed pregnant women in manufacturer maintain pregnancy registers by contacting Sanofi Pasteur Inc. at 800-822-2463 (for Menactra) or by contacting Novartis at 877-311-8972 (for Menveo).

    Breast-feeding

    Data are limited regarding use of the meningococcal conjugate vaccine during breast-feeding and its' excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers. According to the Advisory Committee on Immunization Practices (ACIP), inactivated, polysaccharide vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    Geriatric

    Safety and efficacy have not been established in patients greater than 55 years of age, including geriatric patients. Vaccination with the meningococcal conjugate vaccine (Menactra or Menveo) is not recommended for patients greater than 55 years of age. The meningococcal polysaccharide vaccine (Menomune) is the only meningococcal vaccine indicated for use in geriatric patients.

    Guillain-Barre syndrome

    The FDA-approved product labeling for meningococcal conjugate vaccines carries a precaution regarding the possible risk of Guillain-Barre syndrome (GBS) after vaccination; however, in 2010, ACIP voted to remove the precaution from their recommendations because the benefits of meningococcal vaccination outweigh the risk for recurrent GBS. Shortly after Menactra was released onto the U.S. market in 2005, several cases of GBS were reported to VAERS. Symptom onset was most commonly about 14 days after vaccine receipt. No deaths occurred, and most patients had a full recovery. After a review of the initial data, ACIP determined that there was a small increased risk of GBS after vaccination. Because a history of GBS increases the risk of future GBS cases, the FDA required the addition of a warning against use in patients with a history of GBS to product labeling. ACIP continued to closely monitor the safety of these vaccines after the initial reports. No cases of GBS were reported within 1—42 days after 889,684 vaccine doses administered between January 2005 and March 2010. This additional safety data is what prompted ACIP to remove the GBS precaution from their vaccine recommendations. According to the Menactra product labeling, estimates of the attributable risk of GBS range from 0 to 5 additional cases of GBS per 1,000,000 vaccinees within the 6 week period after vaccination. Data are not available to evaluate the potential risk of Guillain-Barre syndrome after Menveo administration.

    Infants, neonates, premature neonates

    Menactra is indicated for use in infants at least 9 months of age; the safety and efficacy of Menactra have not been established for infants < 9 months of age or neonates. Safety and efficacy of Menveo have not been established in neonates and infants < 2 months of age . In some premature neonates, apnea has been observed after intramuscular vaccination. Consider the infant’s medical status and the vaccine's potential benefits and possible risks when deciding when to administer an intramuscular vaccine such as meningococcal conjugate vaccine to infants born prematurely.

    Syncope

    Syncope, sometimes resulting in falling injury associated with seizure-like movements, has occurred after the administration of meningococcal conjugate vaccine. Observe patients for at least 15 minutes after vaccination to prevent and manage syncopal events.

    ADVERSE REACTIONS

    Severe

    Guillain-Barre syndrome / Delayed / Incidence not known
    myelitis / Delayed / Incidence not known
    anaphylactic shock / Rapid / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known

    Moderate

    erythema / Early / 12.0-30.2
    lymphadenopathy / Delayed / Incidence not known
    hypotension / Rapid / Incidence not known
    wheezing / Rapid / Incidence not known
    dyspnea / Early / Incidence not known

    Mild

    irritability / Delayed / 21.0-56.8
    injection site reaction / Rapid / 9.0-53.0
    myalgia / Early / 10.0-42.8
    fatigue / Early / 38.0-38.0
    inconsolable crying / Delayed / 33.3-33.3
    drowsiness / Early / 16.0-30.2
    anorexia / Delayed / 9.0-30.2
    headache / Early / 5.0-29.0
    vomiting / Early / 3.0-14.1
    malaise / Early / 10.0-14.0
    fever / Early / 1.0-12.2
    nausea / Early / 5.0-12.0
    arthralgia / Delayed / 3.0-8.0
    chills / Rapid / 4.0-8.0
    diarrhea / Early / 7.0-8.0
    rash / Early / 2.0-5.0
    paresthesias / Delayed / Incidence not known
    urticaria / Rapid / Incidence not known
    pruritus / Rapid / Incidence not known
    dizziness / Early / Incidence not known
    syncope / Early / Incidence not known

    DRUG INTERACTIONS

    Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
    Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
    Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
    Siponimod: (Moderate) Administer all non-live vaccines at least 4 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment and for 1 month after discontinuation of siponimod treatment.

    PREGNANCY AND LACTATION

    Pregnancy

    No adequate and well controlled studies have been conducted in pregnant women and the ability of the meningococcal conjugate vaccine to cause fetal harm or affect the reproductive system is unknown. An analysis of 5,065 women enrolled in clinical studies revealed 37 pregnancies among the 3,952 Menveo recipients and 6 pregnancies in the 1,113 patients treated with Menactra. A follow-up of these women found 7 spontaneous abortions and no congenital abnormalities in the Menveo group and no spontaneous abortions and 1 congenital abnormality (hydrocephalus) in the Menactra group. A pregnancy registry spanning from 2005 to 2016 included 222 reports of Menactra exposure for 30 days before or at any time during pregnancy. Out of the 87 available pregnancy outcomes, 2 major birth defects and 6 miscarriages were reported. The manufacturers recommend use during pregnancy only if clearly needed; however according to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated vaccines to pregnant women does not adversely affect the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. Instruct women who become pregnant at the time of vaccination to report the pregnancy to their health care professional. Health care professionals are encouraged to enroll exposed pregnant women in manufacturer maintain pregnancy registers by contacting Sanofi Pasteur Inc. at 800-822-2463 (for Menactra) or by contacting Novartis at 877-311-8972 (for Menveo).

    Data are limited regarding use of the meningococcal conjugate vaccine during breast-feeding and its' excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers. According to the Advisory Committee on Immunization Practices (ACIP), inactivated, polysaccharide vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    The presence of bacterial anti-capsular antibodies has been associated with protection from invasive meningococcal disease. Serogroup A, C, W, and Y capsular polysaccharide (Menactra) or oligosaccharides (Menveo) antigens are individually conjugated to diphtheria toxoid protein. The polysaccharide conjugate vaccine (MenQuadfi) is conjugated to tetanus toxoid protein. Polysaccharide vaccines only elicit a B-cell response, so although antibodies are produced, there is no long-term memory. By coupling the polysaccharides to a carrier protein, a T-cell dependent immune response is generated. A polysaccharide conjugated to a protein carrier also stimulates both B-cell immune response and T-helper cell response to the protein carrier, resulting in antibodies to the protein carrier and immune memory. The diphtheria and/or tetanus toxoid protein does not induce immunity to the diphtheria and/or tetanus antigen. Immunization against diphtheria and/or tetanus does not occur after vaccination with the meningococcal diphtheria toxoid conjugate vaccine or the meningococcal tetanus toxoid conjugate vaccine.

    PHARMACOKINETICS

    The meningococcal conjugate vaccines (Menactra and Menveo) are administered intramuscularly. 
     
    Vaccination does not ensure immunity. In a comparison trial of Menveo and Menactra in adults 19—55 years of age, seroresponse rates to each serogroup 28 days after vaccination were obtained. Serogroup-specific anticapsular antibodies with bactericidal activity were measured using pooled human serum that lacked bactericidal activity as the source of exogenous complement (hSBA). Seroresponse was defined as an after vaccination titer of > 1:8 for subjects with a before vaccination hSBA titer of < 1:4 and as an after vaccination titer at least 4-fold higher than baseline for patients with a before vaccination hSBA titer of at least 1:4. For N. meningitidis serogroup A, 67% had a seroresponse with Menveo and 68% had a seroresponse with Menactra. For serogroup C, 67% had a seroresponse with Menveo and 58% had a seroresponse with Menactra. For serogroup W-135, 50% had a seroresponse with Menveo and 41% had a seroresponse with Menactra. For serogroup Y, 56% had a seroresponse with Menveo and 40% had a seroresponse with Menactra. In another trial, immunogenicity of Menactra was compared to Menomune in adults age 18—55 years. Twenty-eight days after a single dose, a 4-fold rise in antibody titers against N. meningitidis serogroups A, C, Y, and W-135 was observed in 80%, 88%, 73%, and 89%, respectively, of Menactra recipients (n = 1280). These results were similar to those observed with Menomune (n = 1098; 84%, 89%, 79%, 94%, respectively). Immune response obtained from using Menactra as a booster was studied in 781 adults and adolescents, age 15—55 years. In this trial, the percentage of vaccine recipients to achieve a >= 4-fold antibody titer by day 28 for serogroups A, C, Y, W-135 were 95%, 95%, 97%, and 96%, respectively.