The meningococcal vaccine is available as 4 different formulations: meningococcal polysaccharide vaccine (Menomune); meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra); meningococcal oligosaccharide diphtheria toxoid conjugate vaccine (Menveo); meningococcal recombinant vaccine (Trumenba and Bexsero). All 4 vaccines are indicated for the prevention of invasive disease caused by Neisseria meningitidis; Menomune, Menactra, and Menveo are active against serogroups A, C, Y, and W-135, while Trumenba and Bexsero are active against serogroup B. Meningococcal disease is a result of an invasive infection by N. meningitidis; the 5 main N. meningitidis serogroups responsible for meningococcal disease are A, B, C, Y, or W-135. Although relatively uncommon in the U.S., meningococcal disease is fatal in approximately 10% to 15% of patients despite appropriate antibiotic therapy, with an additional 10% to 20% experiencing permanent complications (brain damage and limb loss). Individuals at increased risk for meningococcal disease include infants and children younger than 5 years, adolescents and young adults 16 to 21 years, and the elderly. Meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) and meningococcal oligosaccharide diphtheria toxoid conjugate vaccine (Menveo) are intramuscularly administered vaccines for the prevention of disease caused by N. meningitidis serogroups A, C, Y, and W-135. These vaccines produce similar immune responses for all 4 serogroups as the non-conjugated polysaccharide vaccine (Menomune); however, the conjugated vaccines are more likely to prime immunologic memory because the 4 serogroups are individually conjugated to diphtheria toxoid protein. Thus, the conjugate vaccines are expected to provide a longer duration of immunity towards meningococcal disease and may provide herd immunity through protection from nasopharyngeal carriage. As a result, meningococcal conjugate vaccines have largely replaced the use of the non-conjugate polysaccharide vaccine, and is preferred for younger adults, adolescents, children and select infants in noted risk groups; however, these vaccines are not approved for use in patients 55 years of age and older. The non-conjugated polysaccharide vaccine remains the only licensed meningococcal vaccine approved for use in adults 56 years or older. Routine vaccination is recommended for adolescents 11 to 18 years of age, preferably with 1 dose of a meningococcal conjugate vaccine 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.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
-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 patient, parent, or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
-Record in the patient's permanent record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine. These actions are required by the National Childhood Vaccine Injury Act of 1986.
Route-Specific Administration
Injectable Administration
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.-Menactra solution should be clear to slightly turbid.
-Menveo and MenQuadfi are a clear, colorless solution that is free from visible foreign particles. If discoloration or visible particulate matter are present, discard the vial or syringe.
Intramuscular Administration
-Menactra, MenQuadfi, and Menveo 1 vial presentation (single vial with a pink cap) are supplied as ready to use solution; reconstitution is not necessary.
Reconstitution (Menveo 2 vial presentation only)
-Use the MenCYW-135 liquid conjugate component (Vial 1, gray cap) to reconstitute the MenA lyophilized conjugate component (Vial 2, orange cap) to form Menveo.
-Using a sterile needle and sterile graduated syringe, withdraw the entire contents of the vial of MenCYW-135 liquid conjugate component (Vial 1, gray cap) while slightly tilting the vial.
-Slowly transfer the entire contents of the syringe into the MenA lyophilized conjugate component (Vial 2, orange cap). Invert and shake the reconstituted vial until lyophilized conjugate component is completely dissolved.
-After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine.
-Storage of reconstituted vaccine: If possible, administer immediately after reconstitution; however, reconstituted Menveo may be stored for up to 8 hours at 36 degrees F to 77 degrees F (2 degrees C to 25 degrees C). Do not freeze. Shake well before using. Discard reconstituted vaccine if it has been frozen or not used within 8 hours.
Intramuscular Injection (Menactra, Menveo, and MenQuadfi)-When Daptacel and Menactra are to be given together for children 4 through 6 years, administer the 2 vaccines concomitantly or administer Menactra before Daptacel. Clinical trials found a reduced meningococcal antibody response when Menactra was administered 1 month after Daptacel.
-Do not mix with any other vaccine.
-When concomitant administration of other vaccines is required, administer with different syringes and at different sites.
-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; syncope may occur.
Systemic adverse reactions to meningococcal conjugate vaccine were similar between Menactra and Menveo recipients at least 2 years of age. Among children 2 to 5 years of age, 21% to 22% had irritability, 16% to 18% had drowsiness, 9% to 10% had anorexia, 7% to 8% had diarrhea, and 3% had vomiting. Higher percentages of 9 month-olds who received Menactra had irritability (56.8%), drowsiness (30.2%), fever (12.2%), anorexia (30.2%), and vomiting (14.1%). Inconsolable crying (33.3%) was also noted among infants who received Menactra. Other notable adverse reactions included chills (4% to 8%), nausea (5% to 12%), myalgia (10% to 19%), malaise (10% to 14%), fever (1% to 2%), arthralgia (3% to 8%), rash (2% to 5%), and headache (5% to 29%). With the exception of an increased incidence of fatigue (38%) and myalgia (42.8%), administration of a booster resulted in similar adverse reactions as those observed in adolescents and adults receiving the single-dose primary series. Lymphadenopathy was reported through postmarketing surveillance.
Guillain-Barre syndrome has occurred in temporal relationship after meningococcal conjugate vaccine (Menactra) receipt, and post-marketing data suggest a potential for an increased risk of Guillain-Barre syndrome after Menactra vaccination. Data are not available to evaluate the potential risk of Guillain-Barre syndrome after administration of Menveo. Guillain-Barre syndrome, which is characterized by muscular weakness of the extremities and can lead to paralysis, can occur in a variety of circumstances. Other signs and symptoms of Guillain-Barre syndrome may include tingling, numbness, and a decrease in deep tendon reflexes in extremities; gait difficulties; slurred speech; and swallowing difficulties. Post-marketing, paresthesias, facial palsy, acute disseminated encephalomyelitis, and transverse myelitis have been noted with Menactra. Seventeen reports of Guillain-Barre syndrome after administration of Menactra have been received through the Vaccine Adverse Event Reporting System (VAERS); 15 cases occurred within 6 weeks after vaccination of patients 11 to 19 years of age, and 2 cases have been confirmed in persons 20 years of age and older. All individuals are reported to be recovering or have recovered. The mean time from the date of vaccination to the date of Guillain-Barre syndrome symptom onset for the 17 cases was 15.7 days (range, 2 to 33 days). The Centers for Disease Control (CDC) estimates that the apparent rate of postvaccination Guillain-Barre syndrome is about 1.25 cases per 1 million adolescent and teen vaccinees whereas about 1.2 cases of meningitis are reported per 100,000 people in this age group. As data on background rates of Guillain-Barre syndrome are limited, as meningitis kills up to 14% of patients diagnosed with the condition, and as the link between Guillain-Barre syndrome and meningococcal vaccination is under investigation, the CDC has not altered current meningococcal vaccination recommendations. In a cohort study of 48,899 patients (11 to 21 years of age), the safety of the quadrivalent meningococcal conjugate vaccine, Menveo, was evaluated. A temporal association between occurrence of Bell's palsy and receipt of Menveo was observed when it was given concomitantly with other vaccines. The relative incidence (RI) for Bell's palsy was statistically significant (adjusted RI: 2.9; 95% CI: 1.1 to 7.5), risk was further increased in patients receiving concomitant vaccines (RI = 5; 95% CI = 1.4 to 17.8), and no increased risk was observed for those without concomitant vaccine administration (RI = 1.1; 95% CI = 0.2 to 5.5). Report any suspected cases of Guillain-Barre syndrome or Bell's palsy that occur in vaccine recipients.
Allergic and anaphylactoid reactions with the use of meningococcal conjugate vaccine (Menactra and Menveo) have been reported in post-marketing safety data. Anaphylactic shock, wheezing, difficulty breathing (dyspnea), upper airway swelling (angioedema), urticaria, pruritus, and hypotension have been noted. During administration of either Menactra or Menveo, health care professionals should take precautions to prevent allergic reactions and have immediate availability of agents used in the treatment of severe anaphylaxis (e.g., epinephrine 1 mg/mL injection). Subsequent doses of Menactra or Menveo are contraindicated if a patient has a severe allergic reaction after a previous dose of the vaccine or any component of the vaccine.
Syncope, vasovagal syncope, and dizziness have been reported post-marketing with the meningococcal conjugate vaccine (Menveo and Menactra). Syncope, sometimes associated with falling, has occurred after vaccination with Menveo. Carefully observe patients for approximately 15 minutes after vaccine administration. Closely observe patients for fainting warning signs and symptoms such as paleness, sweating, dizziness, ringing in ears, or vision changes. Syncope with tonic-clonic movements and other seizure-like activity has been noted after the meningococcal diphtheria toxoid conjugate vaccine and other vaccine administration. If fainting with or without seizure-like activity occurs, place the patient in a position to help restore blood flow to the brain. Tonic-clonic activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
Among meningococcal conjugate vaccine recipients, 33% to 53% had an injection site reaction mainly consisting of pain and tenderness after either Menactra or Menveo. Induration at the site was noted in 9% to 18%, and erythema was noted in 12% to 30.2%. Injection site pruritus, inflammation, and swelling have also been noted. Extensive swelling of the injected limb (may be associated with erythema, warmth, tenderness or pain at the injection site) has been noted in post-marketing reports.
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.
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.
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.
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.
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.
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.
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.
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, 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.
General Dosing Information
Routine Immunization
-Routine vaccination of all persons 11 to 18 years of age, preferably at age 11 or 12 years, with 1 dose of meningococcal groups A, C, W, and Y vaccine (Menveo, Menactra, or MenQuadfi) is recommended by the Advisory Committee on Immunization Practices (ACIP).
-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.
-Pediatric patients who have received meningococcal groups A, C, W, and Y vaccine prior to their 10th birthday should still receive the routinely recommended doses at age 11 to 12 years and 16 years. For children whom boosters are recommended, follow the booster schedule for patients at increased risk.
Immunization of Special Populations
-Patients at increased risk for meningococcal disease (e.g., anatomic or functional asplenia, sickle cell disease, HIV infection, persistent complement component deficiency, receiving a complement inhibitor (e.g., eculizumab, ravulizumab))-First dose at 8 weeks: a 4-dose series using Menveo is recommended.
-First dose at 3 to 6 months: a 3- or 4-dose series using Menveo; administer dose 2 (and dose 3 if applicable) at least 8 weeks after the previous dose until a dose is received at age 7 months or older, followed by an additional dose at least 12 weeks later and after age 12 months.
-First dose at 7 to 23 months: a 2-dose series using Menveo, with a dosing interval of 12 weeks and the second dose administered after 12 months of age, is recommended. Menactra may be used in infants and children 9 to 23 months with persistent complement component deficiency or receiving a complement inhibitor. Administer a 2 dose series, with a dosing interval of at least 12 weeks (an interval of 8 weeks may be used for infants and children receiving vaccine prior to travel).
-First dose at 2 years and older: 2 doses of Menveo, Menactra, or MenQuadfi given at least 8 weeks apart. Administer Menactra at least 4 weeks after completion of all pneumococcal doses.
-Patients who travel to or are residents of countries where meningococcal disease is hyperendemic or epidemic, who are at risk due to a community outbreak, microbiologists routinely exposed to Neisseria meningitidis, military recruits, or first-year college students who live in residential housing if they did not receive a dose at age 16 years or older-First dose at 8 weeks: a 4-dose series using Menveo is recommended.
-First dose at 3 to 6 months: a 3- or 4-dose series using Menveo; administer dose 2 (and dose 3 if applicable) at least 8 weeks after the previous dose until a dose is received at age 7 months or older, followed by an additional dose at least 12 weeks later and after age 12 months.
-First dose at 7 to 23 months: a 2-dose series using Menveo, with a dosing interval of 12 weeks and the second dose administered after 12 months of age, is recommended. Menactra may be used in infants and children 9 to 23 months. Administer a 2 dose series, with a dosing interval of at least 12 weeks (an interval of 8 weeks may be used for infants and children receiving vaccine prior to travel).
-First dose at 2 years and older: 1 dose of Menveo, Menactra, or MenQuadfi. Administer Menactra at least 4 weeks after completion of all pneumococcal doses.
-For all adults with HIV, administer 2 doses of Menveo and MenQuadfi at least 8 weeks apart with a booster dose every 5 years.
-Booster doses of meningococcal groups A, C, W, and Y vaccine are recommended for patients who remain at increased risk for meningococcal disease. Specifically, a booster dose of meningococcal groups A, C, W, and Y vaccine is recommended after 3 years for patients who received the primary dose or series at age 2 months to 6 years and after 5 years for patients who received the primary dose or series at 7 years of age or older. After the initial booster, patients who remain at risk should continue to receive boosters at 5 year intervals.
For meningococcal infection prophylaxis due to Neisseria meningitidis serogroups A, C, W, and Y:
-for primary immunization:
Intramuscular dosage (Menveo 1-vial presentation only):
Adults 18 to 55 years: 0.5 mL IM as a single dose. A 1- or 2-dose primary series is recommended depending on indication and age at first dose receipt.
Children and Adolescents 10 to 17 years: 0.5 mL IM as a single dose. A 1- or 2-dose primary series is recommended depending on indication and age at first dose receipt.
Intramuscular dosage (Menveo 2-vial presentation only):
Adults 18 to 55 years: 0.5 mL IM as a single dose. A 1- or 2-dose primary series is recommended 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. A 1- or 2-dose primary series is recommended depending on indication and age at first dose receipt.
Infants and Children 7 months to 1 year: 0.5 mL IM 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.
Infants 2 to 6 months: 0.5 mL IM as a 4-dose series 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. A 1- or 2-dose primary series is recommended depending on indication and age at first dose receipt.
Children and Adolescents 2 to 17 years: 0.5 mL IM as a single dose. A 1- or 2-dose primary series is recommended depending on indication and age at first dose receipt.
Infants and Children 9 months to 1 year: 0.5 mL IM as a 2-dose series given 3 months apart.
Intramuscular dosage (MenQuadfi only):
Adults: 0.5 mL IM as a single dose. A 1- or 2-dose primary series is recommended depending on indication and age at first dose receipt.
Children and Adolescents 2 to 17 years: 0.5 mL IM as a single dose. A 1- or 2-dose primary series is recommended depending on indication and age at first dose receipt.
-for booster dosing or revaccination of patients who remain at increased risk for meningococcal infection:
Intramuscular dosage (Menactra and Menveo):
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. 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.
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. 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.
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.
Intramuscular dosage (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. The FDA-approved product labeling recommends that a single booster dose may be given if at least 3 years have elapsed since the prior dose and the risk of infection continues.
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. The FDA-approved product labeling recommends that a single booster dose may be given in adolescents 13 years and older if at least 3 years have elapsed since the prior dose and the risk of infection continues.
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.
Maximum Dosage Limits:
-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
10 to 11 years: 0.5 mL IM.
2 to 9 years: 0.5 mL IM of Menactra, MenQuadfi, or Menveo 2-vial presentation; safety and efficacy of Menveo 1-vial presentation have not been established.
1 year: 0.5 mL IM of Menactra or Menveo 2-vial presentation; safety and efficacy of MenQuadfi and Menveo 1-vial presentation have not been established.
-Infants
9 to 11 months: 0.5 mL IM of Menactra or Menveo 2-vial presentation; safety and efficacy of MenQuadfi and Menveo 1-vial presentation have not been established.
2 to 8 months: 0.5 mL IM of Menveo 2-vial presentation; safety and efficacy of Menactra, MenQuadfi, and Menveo 1-vial presentation have not been established.
1 month: Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Albuterol; Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Betamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Bimekizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticosteroids (systemic): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticotropin, ACTH: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Cortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deflazacort: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Dexamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hydrocortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Methylprednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
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.
Prednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Prednisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
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 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Triamcinolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Vamorolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
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.
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.
-Special Populations
Pediatrics
Twenty eight days after a single Menactra dose to 423 patients 11-18 years of age, 92%, 91%, 81%, and 96% developed at least a four-fold increase in antibody titers against N. meningitidis serogroups A, C, Y, and W-135, respectively. Among children 2-3 years of age, a serum bactericidal assay titer of at least 1:8 against N. meningitidis was obtained for serogroup A in 73%, serogroup C in 63%, serogroup Y in 88%, and serogroup W-135 in 63%. Higher percentages of children 4-10 years of age had a titer of at least 1:8 twenty-eight days after vaccination: 81% for serogroup A, 79% for serogroup C, 99% for serogroup Y, and 85% for serogroup W-135.
In a comparison trial of Menveo and Menactra in patients 11-18 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, 75% had a seroresponse with Menveo and 66% had a seroresponse with Menactra. For serogroup C, 75% had a seroresponse with Menveo and 73% had a seroresponse with Menactra. For serogroup W-135, 75% had a seroresponse with Menveo and 63% had a seroresponse with Menactra. For serogroup Y, 68% had a seroresponse with Menveo and 41% had a seroresponse with Menactra.