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meningococcal A C Y and W-135 diphtheria conjugate vaccine (Menactra, Menveo)

 

Classes: Vaccines, Inactivated, Bacterial; Vaccines, Travel

Dosing and uses of Menactra, Menveo (meningococcal A C Y and W-135)

 

Adult dosage forms and strengths

IM solution

  • 0.5mL/dose

 

Meningococcal Vaccination

Indicated active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in high risk adults

0.5 mL/dose Im

 

Immunization for High-Risk Conditions (ACIP Guidelines)

MenACWY is preferred for adults with any of the following indications who are aged ≤55 yr as well as for adults aged ≥56 years who a) were vaccinated previously with MenACWY and are recommended for revaccination, or b) for whom multiple doses are anticipated

Meningococcal polysaccharide vaccine (MPSV4 [Menomune]) is preferred for adults aged ≥56 years who have not received MenACWY previously and who require a single dose only (eg, travelers)

HIV infection is not an indication for routine vaccination

Asplenia or complement deficiencies

  • Indicated in adults of all ages with functional asplenia or persistent complement component deficiencies
  • Menactra or Menveo: Administer 2 doses at least 2 months apart to adults of all ages with functional asplenia or persistent complement component deficiencies
  • Booster dose: Every 5 years

Microbiologists

  • Administer a single dose of meningococcal vaccine to microbiologists routinely exposed to isolates of Neisseria meningitidis
  • Booster dose: Every 5 years

Military recruits

  • Administer a single dose

First-year college students

  • Administer a single dose for first-year college students (up through age 21 years) who are living in residence halls should be vaccinated if they have not received a dose on or after their 16th birthday

Community outbreak

  • Administer a single dose for persons at risk during an outbreak attributable to a vaccine serogroup

Travel/reside in hyperendemic/epidemic countries

  • Administer a single dose for adults who travel to or reside in countries in which meningococcal disease is hyperendemic or epidemic, including countries in the African meningitis belt or the Hajj
  • International travelers should receive a booster dose of MenACWY if the last dose was administered >4 years previously
  • Vaccination in the 3 years before the date of travel is required by the government of Saudi Arabia for all travelers to Mecca during the annual Hajj

 

Administration

Preferably in deltoid region

Administer IM; do not administer IV or SC

 

Pediatric dosage forms and strengths

IM solution

  • 0.5mL/dose

 

Primary Immunization (Adolescent)

Routine primary vaccination of adolescents recommended at age 11 or 12 years unless high risk or outbreak requires earlier vaccination at younger age

11-12 years: 0.5 mL IM once; CDC recommends booster dose at age 16 yr

11-12 years (HIV infection): 2-dose primary series of 0.5 mL IM with at least 8 wk between doses (CDC guidelines)

Catch-up schedule (Adolescent)

  • Administer vaccine at age 13 through 18 years if not previously vaccinated
  • If first dose is administered at age 13 through 15 years, a booster dose should be given at age 16 through 18 years; minimum interval between doses is 8 weeks
  • If first dose administered at age 16 or older, a booster dose is not needed

First-year college students

  • First-year college students (up to age 21 yr) living in residence halls should receive at least 1 dose of MenACWY before college entry; the preferred timing of the most recent dose is on or after their 16th birthday
  • If only 1 dose of vaccine was administered before the 16th birthday, a booster dose should be administered before enrollment

 

Immunization for High-Risk Conditions (ACIP Guidelines)

Asplenia

  • Indicated for children with anatomic or functional asplenia (including sickle cell disease)
  • Menveo for children aged <19 months: 4-dose infant series given at 2, 4, 6, and 12 through 15 months
  • For children aged 19 through 23 months who have not completed a series of MenHibrix or Menveo, administer 2 primary doses of Menveo at least 3 months apart
  • For children aged ≥24 months who have not received a complete series of MenHibrix or Menveo or Menactra, administer 2 primary doses of either Menactra or Menveo at least 2 months apart
  • Booster dose: Every 5 years

Complement Deficiency

  • For children with persistent complement component deficiency
  • For children younger than 19 months of age, administer a 4-dose infant series of Menveo at 2, 4, 6, and 12 through 15 months of age
  • For children 7 through 23 months who have not initiated vaccination, 2 options exist depending on age and vaccine brand:
  • -a. For children who initiate vaccination with Menveo at 7 months through 23 months of age, a 2-dose series should be administered with the 2nd dose after 12 months of age and at least 3 months after the first dos
  • -b. For children who initiate vaccination with Menactra at 9 months through 23 months of age, a 2-dose series of Menactra should be administered at least 3 months apart
  • For children ≥24 months who have not received a complete series of any meningococcal vaccine, administer 2 primary doses of either Menactra or Menveo at least 2 months apart
  • Booster dose: Every 5 years

Travel/reside in hyperendemic/epidemic countries

  • For children who travel to or reside in countries in which meningococcal disease is hyperendemic or epidemic, including countries in the African meningitis belt or the Hajj
  • Administer an age-appropriate formulation and series of Menactra (minimum age 9 months) or Menveo (minimum age 2 months) for protection against serogroups A and W meningococcal disease
  • Note: Prior receipt of MenHibrix is not sufficient for children traveling to the meningitis belt or the Hajj because it does not contain serogroups A or W
  • International travelers should receive a booster dose of MenACWY if the last dose was administered >4 years previously
  • Vaccination in the 3 years before the date of travel is required by the government of Saudi Arabia for all travelers to Mecca during the annual Hajj

Community outbreak

  • For children at risk during a community outbreak attributable to a vaccine serogroup, administer or complete an age- and formulation-appropriate series of MenHibrix, Menactra, or Menveo

 

Dosing Considerations

Indicated for routine prophylaxis initiated during adolescence

CDC guidelines provide guidance for high risk infants/children (eg, sickle cell, asplenia, persistent complement deficiencies, traveling to endemic areas, outbreaks)

Schedule for initiating vaccine at a particular age (product specific)

  • Menveo (age 2 months): FDA approved for 4-dose series given at 2, 4, 6, and 12 months of age
  • Meveo (age 7-23 months): FDA approved for 2-dose series with 2nd dose being given in 2nd year of life at least 3 months after the first dose
  • Menveo (age 2-10 years): Single dose; for children aged 2 yr through 5 yr at continued high risk of meningococcal disease, a 2nd dose may be administered 2 months after the 1st dose
  • Menveo (adolescents and adults aged 11 through 55 years): FDA approved as a single dose
  • Menactra: (age 9-23 months): FDA approved for 2-dose series given 3 months apart
  • Menactra: (age 2-55 years): FDA approved as single dose with a booster dose (if at least 4 yr have elapsed) in high risk individuals aged 15 yr through 55 yr

 

Administration

Administer IM only; do not administer IV, SC, or Id

Give IM injection, preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in toddlers, adolescents, and adults

 

Geriatric dosage forms and strengths

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)

 

Menactra, Menveo (meningococcal A C Y and W-135) adverse (side) effects

>10%

Tenderness at injection site

Erythema

Swelling

Irritability

Abnormal crying

Drowsiness

Appetite loss

Induration

Vomiting

Fever

Malaise

Headache

 

Postmarketing Reports

Data available from persons aged 11-55 years

Ear: Impaired hearing, ear pain, vertigo, vestibular disorder

Eye: Eyelid ptosis

General: Injection site pruritus, pain, erythema, inflammation and swelling, fatigue, malaise, pyrexia

Immune system: Hypersensitivity/anaphylaxis

Infections and infestations: Vaccination site cellulitis

Investigation: Alanine aminotransferase increased, body temperature increased

Musculoskeletal and connective tissue: Arthralgia, bone pain, myalgia

Nervous system: Guillain-Barre syndrome, paresthesia, dizziness, syncope, tonic convulsion, headache, facial paresis, balance disorder

Respiratory: Oropharyngeal pain

Skin: Skin exfoliation

 

Warnings

Contraindications

Severe allergic reaction (eg, anaphylaxis)

Hypersensitivity to any component

 

Cautions

Syncope may occur

May potentially increase risk of Guillain-Barre Syndrome; causality unknown

Not indicated for N. meningitidis serogroup B

Not immunizing agent for diphtheria

Patients with bleeding disorder

Immunosuppressed patients

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Unknown whether distributed in breast milk; use caution

 

Pregnancy 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.

 

Pharmacology of Menactra, Menveo (meningococcal A C Y and W-135)

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

 

Administration

IM Preparation

Menactra

  • Clear to slightly turbid solution
  • Withdraw the 0.5 mL dose of vaccine from the single-dose vial using a sterile needle and syringe

Menveo

  • Mix lyophilized vaccine powder with diluent provided Invert and mix thoroughly
  • Resulting solution should be clear and colorless

 

IM Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration

Preferably administered in deltoid region

 

Storage

Do not freeze

Store refrigerated, away from freezer compartment, at 36-46 degrees Fahrenheit

Protect from light

Do not use after the expiration date

Reconstituted vaccine should be used immediately; may be held at or below 77 degrees Fahrenheit for up to 8 hr