AdultPediatricGeriatricDosage Forms & Strengths IM solution 0.5 mL/single-dose vial (Menactra) 0.5 mL/1-vial presentation (Menveo) 0.5 mL/2-vial presentation (Menveo)* *2-vial presentation combines Vial 1 (gray cap) containing the MenCYW-135 liquid conjugate component and Vial 2 (orange cap) containing the MenA lyophilized conjugate to form a single dose (0.5 mL) Meningococcal Vaccination Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 0.5 mL/dose IM Menveo (1-vial or 2-vial presentation) or Menactra All formulations: 0.5 mL/dose IM x 1 dose Booster (15-55 years): 0.5 mL IM x 1 dose to individuals who are at continued risk for meningococcal disease if at least 4 years have elapsed since last dose Menactra 2-55 years: 0.5 mL IM x 1 dose Booster (15-55 years): Administer 0.5 mL to individuals who are at continued risk for meningococcal disease if at least 4 years have elapsed since last dose CDC recommendations for special situations https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf Anatomical or functional asplenia (including sickle cell disease), HIV infection, persistent complement component deficiency, complement inhibitor (eg, eculizumab, ravulizumab) use: 2-dose series of Menactra or Menveo at least 8 weeks apart and revaccinate every 5 years if risk remains Travel in countries with hyperendemic or epidemic meningococcal disease, or microbiologists routinely exposed to Neisseria meningitidis: 1 dose Menactra, or Menveo and revaccinate every 5 years if risk remains First-year college students who live in residential housing (if not previously vaccinated at age ≥16 years or older) or military recruits: 1 dose Menactra or Menveo Dosing Considerations No prevention against N. meningitidis serogroup B infections Menveo Supplied as 1-vial or 2-vial presentation Dosage Forms & Strengths IM solution 0.5 mL/single-dose vial (Menactra) 0.5 mL/1-vial presentation (Menveo) 0.5 mL/2-vial presentation (Menveo)* *2-vial presentation combines Vial 1 (gray cap) containing the MenCYW-135 liquid conjugate component and Vial 2 (orange cap) containing the MenA lyophilized conjugate to form a single dose (0.5 mL) Meningococcal Vaccination Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 2 months to 55 years of age (Menveo) or 9 months to 55 years of age (Menactra) 0.5 mL/dose IM CDC recommendations Dose 1 at age 11-12 years Dose 2 (booster) at age 16 years Also see CDC Immunization Schedules Catch-up vaccination Dose 1 at 13-15 years Dose 2 (booster) at 16-18 years (at least 8 weeks after initial dose) Menveo (2-vial presentation) Initiated at 2 months: 4-dose series at 2, 4, 6, and 12 months of age Initiated at 7-23 months: 2-dose series with second dose administered in second year of life and at least 3 months after first dose Initiated at 2-10 years: 0.5 mL IM x 1 dose; for children aged 2-5 years at continued high risk of meningococcal disease, administer second dose 2 months after first dose Initiated at 12-18 years: 0.5 mL IM x 1 dose Booster (15-18 years): Administer 0.5 mL using either one-vial or two-vial presentation to individuals who are at continued risk for meningococcal disease if at least 4 years have elapsed since last dose Menactra Initiated at 9-23 months: 2-dose series with second dose administered in second year of life and at least 3 months after first dose Initiated at 2-18 years: 0.5 mL IM x 1 dose Booster (15-18 years): Administer 0.5 mL to individuals who are at continued risk for meningococcal disease if at least 4 years have elapsed since last dose High-risk condition https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf Includes anatomic or functional asplenia (including sickle cell disease), HIV infection, persistent complement component deficiency, complement inhibitor (eg, eculizumab, ravulizumab) use Menveo Initiated at 2 months: 4-dose series (additional 3 doses at age 4, 6 and 12 months) Initiated at 3-6 months: 3- or 4- dose series (dose 2 [and dose 3 if applicable] at least 8 weeks after previous dose until dose is received at ≥7 months, followed by an additional dose at least 12 weeks later and after 12 months) Initiated at 7-23 months: 2-dose series (dose 2 at least 12 weeks after dose 1 and after age 12 months) Initiated at ≥24 months: 2-dose series at least 8 weeks apart Menactra (9-23 months) Persistent complement component deficiency or complement inhibitor use: 2-dose series at least 12 weeks apart Anatomic or functional asplenia, sickle cell disease, or HIV infection: Not recommended Menactra (≥2 years) Anatomic or functional asplenia, sickle cell disease, HIV infection, persistent complement component deficiency or complement inhibitor use: 2-dose series at least 8 weeks apart Must be administered at least 4 weeks after completion of PCV13 series Travel in countries with hyperendemic or epidemic meningococcal disease, including countries in the African meningitis belt or during the Hajj Based on CDC recommendations Menveo (2–23 months) Initiated at 2 months: 4-dose series (additional 3 doses at age 4, 6 and 12 months) Initiated at 3-6 months: 3- or 4- dose series (dose 2 [and dose 3 if applicable] at least 8 weeks after previous dose until dose is received at ≥7 months, followed by an additional dose at least 12 weeks later and after 12 months) Initiated at 7-23 months: 2-dose series (dose 2 at least 12 weeks after dose 1 and after age 12 months) Initiated at ≥24 months: 0.5 mL IM x 1 dose Menactra Initiated at 9-23 months: 2-dose series (dose 2 at least 12 weeks after dose 1; dose 2 may administer as early as 8 weeks after dose 1 in travelers Initiated at ≥2 years: 1 dose First-year college students who live in residential housing (if not previously vaccinated at age ≥16 years) or military recruits H5 Menveo or Menactra: 1 dose Dosing Considerations No prevention against N. meningitidis serogroup B infections Menveo Supplied as 1-vial or 2-vial presentation Safety and efficacy of Menactra and Menveo not established in adults aged >55 yr (Menomune A/C/Y/W-135 recommended for 1 time doses in travelers) >10% Menveo 7-9 months Erythema >50 mm (15%) Tenderness, severe (11%) 12 months Erythema >50 mm (13%) 2-5 years Injection site pain, any (33%) Erythema, any (27%) Irritability, any (21%) Induration, any (18%) Sleepiness, any (16%) 6-10 years Injection site pain (39%) Erythema (28%) Headache (18%) Induration (17%) Malaise (14%) Menactra 2-5 years Injection site pain, any (35%) Erythema, any (25%) Irritability, any (22%) Induration, any (18%) Sleepiness, any (18%) 6-10 years Injection site pain, any (45%) Erythema, any (22%) Induration, any (13%) Headache, any (13%) Malaise, any (11%) 1-10% Menveo 7-9 months Induration >50 mm (ages 7-9 months) (8%) 12 months Tenderness, severe (10%) Induration >50 mm (8%) 2-5 years Change in eating, any (9%) Diarrhea, any (7%) Injection site pain, moderate (6%) Irritability, moderate (6%) Erythema, moderate (5%) Headache, any (5%) Rash, any (4%) Sleepiness, moderate (3%) Induration, moderate (2%) Fever, any (2%) Injection site pain, severe (1%) Erythema, severe (1%) Irritability, severe (1%) Sleepiness, severe (1%) Change in eating, severe (1%) Diarrhea, moderate (1%) Headache, moderate (1%) Arthralgia, moderate (1%) Vomiting, moderate (1%) 6-10 years Myalgia, any (10%) Nausea, any (8%) Arthralgia, any (6%) Chills, any (5%) Rash, any (5%) Headache, moderate (3%) Malaise, moderate (3%) Myalgia, moderate (2%) Nausea, moderate (2%) Fever, any (2%) Headache, severe (1%) Malaise, severe (1%) Myalgia, severe (1%) Nausea, severe (1%) Arthralgia, moderate (1%) Chills, moderate (1%) Fever, moderate (1%) Menactra 2-5 years Change in eating, any (10%) Injection site pain, moderate (8%) Diarrhea, any (8%) Irritability, moderate (7%) Headache, any (6%) Sleepiness, moderate (5%) Rash, any (5%) Erythema, moderate (3%) Induration, moderate (2%) Change in eating, moderate (2%) Fever, any (2%) Irritability, severe (1%) Sleepiness, severe (1%) Diarrhea, moderate (1%) Headache, moderate (1%) Arthralgia, moderate (1%) Vomiting, moderate (1%) 6-10 years Myalgia, any (10%) Injection site pain, any (10%) Nausea, any (6%) Chills, any (5%) Arthralgia, any (4%) Rash, any (3%) Malaise, moderate (3%) Injection site pain, severe (2%) Erythema, moderate (2%) Induration, moderate (2%) Headache, moderate (2%) Myalgia, moderate (2%) Nausea, moderate (2%) Headache, severe (1%) Malaise, severe (1%) Myalgia, severe (1%) Arthralgia, moderate (1%) Chills, moderate (1%) <1% Menveo 2-5 years Induration, severe (0.4%) Fever, moderate (0.4%) Diarrhea, severe (0.1%) Arthralgia, severe (0.1%) Vomiting, severe (0.1%) Menactra 2-5 years Injection site pain, severe (0.4%) Erythema, severe (0.3%) Induration, severe (0.3%) Change in eating, severe (0.3%) Headache, severe (0.3%) Fever, moderate (0.3%) 6-10 years Nausea, severe (0.4%) Arthralgia, severe (0.4%) Chills, severe (0.4%) Fever, severe (0.4%) Erythema, severe (0.2%) Postmarketing Experience Blood and lymphatic system disorders: Local lymphadenopathy Ear and labyrinth disorders: Hearing impaired, ear pain, vertigo, vestibular disorder Eye disorders: Eyelid ptosis General disorders and administration site conditions: Injection site pruritus; pain; erythema; inflammation; and swelling, including extensive swelling of the vaccinated limb; fatigue; malaise; pyrexia Immune system disorders: Hypersensitivity reactions, including anaphylaxis Infections and infestations: Vaccination site cellulitis Injury, poisoning, and procedural complications: Fall, head injury Investigation: ALT increased; body temperature increased Musculoskeletal and connective tissue disorders: Arthralgia, bone pain Nervous system disorders: Dizziness, syncope, tonic convulsion, headache, facial paresis, balance disorder Respiratory, thoracic, and mediastinal disorders: Oropharyngeal pain Skin and SC tissue disorders: Skin exfoliation Contraindications History of severe allergic reaction (eg, anaphylaxis) to any component of vaccine, or to any other diphtheria toxoid-containing vaccine Cautions Ensure appropriate medical treatment is available should an allergic reaction (eg, anaphylactic reaction) occurs Syncope reported; place proper protocols to avoid injury from syncope Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to drug Certain complement deficiencies and treatments that inhibit terminal complement activation (eg, eculizumab) may increase the patient’s risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, Y and 20 W-135, even if antibodies develop following vaccination Persons previously diagnosed with Guillain-Barre syndrome (GBS) may be at increased risk of GBS following therapy; consider the potential benefits and risks before administering; GBS has been reported in temporal relationship following administration of therapy Apnea observed in some infants born prematurely; consider the potential benefits and risks before administering in premature infants Drug interaction overview Other vaccines Do not mix meningococcal vaccine or any of its components with any other vaccine or diluent in same syringe or vial Immunosuppressives Immunosuppressive therapies, such as irradiation, antimetabolite medications, alkylating agents, cytotoxic drugs, and corticosteroids (when used in greater than physiologic doses) may reduce immune response to vaccine Not evaluated in persons receiving such therapies Pregnancy There are no adequate and well-controlled studies in pregnant females Available data do not suggest an increased risk of major birth defects and miscarriage in females who received vaccine within 28 days before conception or during pregnancy Animal data A developmental toxicity study was performed in female rabbits administered 0.5 mL (at each occasion) before mating and during gestation This study revealed no adverse effects on fetal or preweaning development Lactation It is not known whether the vaccine components are excreted in human milk Data are not available to assess effects of vaccine in breastfed infant or on milk production/excretionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Presence of bacteriocidal anti-capsular meningococcal antibodies associated with protection from invasive meningococcal disease Meningococcal serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein carrier Induces production of bactericidal antibodies directed against the capsular polysaccharides of serogroups A, C, Y and W-135 Preparation Menactra Withdraw 0.5 mL from vial Menveo (1-vial presentation) No reconstitution required Withdraw 0.5 mL from vial (pink cap) Menveo (2-vial presentation) Withdraw contents of Vial 1 (gray cap) and reconstitute Vial 2 (orange cap) Invert Vial 2 and shake well until lyophilized conjugate is fully dissolved Once reconstituted, withdraw 0.5 mL from vial containing reconstituted vaccine Administer immediately or store at 36-77ºF (2-25ºC) for up to 8 hr IM Administration Menveo: Solution appears clear, colorless, free from visible foreign