Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine

Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals.

• Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine is available under the following different brand names: Menactra, Menveo

Common side effects of Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine include:

• injection site reactions (pain, redness, swelling, or a hard lump)
• headache
• muscle pain
• fatigue
• tiredness
• nausea
• vomiting
• loss of appetite
• fever
• chills
• rash
• joint or muscle pain
• fainting
• persistent crying
• fussiness
• irritability
• sleepiness
• diarrhea

Serious side effects of Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness
• weakness
• fast heartbeats
• severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine),
• high fever
• unusual behavior
• seizures (after receiving the vaccine)

Rare side effects of Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

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

Adult dosage

• 0.5 mL/dose IM
• Menveo (1-vial or 2-vial presentation) or Menactra
  • All formulations: 0.5 mL/dose IM × 1 dose
  • Booster (15-55 years): 0.5 mL IM × 1 dose to individuals who are at continued risk for meningococcal disease if at least 4 years have elapsed since the last dose
• Menactra
  • 2-55 years: 0.5 mL IM × 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 the 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 for at least 8 weeks apart and revaccinate every 5 years if the risk remains
  • Travel in countries with hyperendemic or epidemic meningococcal disease or microbiologists routinely exposed to N meningitidis: 1 dose of 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 of Menactra or Menveo

Pediatric dosage

• 0.5 mL/dose IM
• CDC recommendations
  • Dose 1 at age 11-12 years
  • Dose 2 (booster) at age 16 years
• 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 ages 2, 4, 6, and 12 months
  • Initiated at 7-23 months: 2-dose series with the second dose administered in the second year of life and at least 3 months after the first dose
  • Initiated at 2-10 years: 0.5 mL IM × 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 × 1 dose
  • Booster (15-18 years): Administer 0.5 mL using either one-vial or two-vial presentation to individuals who are at a continued risk for meningococcal disease if at least 4 years have elapsed since the last dose
• Menactra
  • Initiated at 9-23 months: two-dose series with the second dose administered in the second year of life and at least 3 months after the first dose
  • Initiated at 2-18 years: 0.5 mL IM × one dose
  • Booster (15-18 years): Administer 0.5 mL to individuals who are at a continued risk for meningococcal disease if at least 4 years have elapsed since the 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 the previous dose until the dose is received at 7 months and older, 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 and more: 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 and older)
  • 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 the previous dose until the dose is received at 7 months and older, 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 greater than 24 months: 0.5 mL IM × 1 dose
• Menactra
  • Initiated at 9-23 months: 2-dose series (dose 2 at least 12 weeks after dose 1; dose 2 may be administered as early as 8 weeks after dose 1 in travellers
  • Initiated at greater than 2 years: 1 dose
  • First-year college students who live in residential housing (if not previously vaccinated at an age older than 16 years) or military recruits H5
• Menveo or Menactra: 1 dose

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine has no noted severe interactions with any other drugs
• Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine has no noted serious interactions with any other drugs
• Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine has no noted moderate interactions with any other drugs
• Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or any other diphtheria toxoid-containing vaccine

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Meningococcal A C Y and W-135 Diphtheria Conjugate Vaccine?"

Cautions

• Ensure appropriate medical treatment is available should an allergic reaction (eg, anaphylactic reaction) occur
• 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
• People previously diagnosed with Guillain-Barre syndrome (GBS) may be at an increased risk for 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 infantsDrug interaction overview
• Other vaccines
  • Do not mix the meningococcal vaccine or any of its components with any other vaccine or diluent in the 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 the immune response to the vaccine
  • Not evaluated in people receiving such therapies

Pregnancy and Lactation

• There are no adequate and well-controlled studies on pregnant women
• Available data do not suggest an increased risk for major birth defects and miscarriage in women who received the vaccine within 28 days before conception or during pregnancy
• Lactation
  • It is not known whether the vaccine components are excreted in human milk
  • Data are not available to assess the effects of the vaccine in breastfed infants or on milk production/excretion