Menactra

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  • Vaccines
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Menactra Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Neisseria meningitidis polysaccharides 4mcg each of Group A, C, Y, and W-135; per 0.5mL; (diphtheria toxoid conjugate); soln for IM inj; preservative-free.

    How Supplied

    Single-dose vials—5

    Storage

    • Store at 2° to 8°C (35° to 46°F). Do not freeze. Frozen/previously frozen product should not be used. Do not use after the expiration date. Discard any unused portion.

    Manufacturer

    Sanofi Pasteur, Inc.

    Mechanism of Action

    The presence of bactericidal anti-capsular meningococcal antibodies has been associated with protection from invasive meningococcal disease. Menactra induces the production of bactericidal antibodies specific to the capsular polysaccharides of serogroups A, C, Y and W-135.

    Menactra Indications

    Indications

    Meningitis immunization.

    Menactra Dosage and Administration

    Adults and Children

    <9mos: not recommended. Give by IM inj only in deltoid region. Primary vaccination: 9–23mos: 0.5mL given as 2-dose series three months apart; 2–55yrs: 0.5mL once. Booster vaccination: 15–55yrs: may give a single (0.5mL) dose for those at continued risk, if at least 4yrs have elapsed since the prior dose.

    Menactra Contraindications

    Contraindications

    Severe allergic reaction to any previous meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM197-containing vaccine.

    Menactra Boxed Warnings

    Not Applicable

    Menactra Warnings/Precautions

    Warnings/Precautions

    Have epinephrine inj (1:1000) available. History of Guillain-Barre syndrome. Immunosuppressed. Risk of syncope. Adults >55yrs old. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Guillain-Barré Syndrome

    • Consider the potential benefits and risks of administering Menactra in persons previously diagnosed with Guillain-Barré Syndrome (GBS) due to an increased risk of GBS after receipt of Menactra.

    • Temporal relationship has been reported with GBS following administration of Menactra.

    Preventing and Managing Allergic Vaccine Reactions 

    • Have epinephrine and other appropriate agents immediately available in case an acute anaphylactic reaction occurs.

    • Review the patient’s immunization history for hypersensitivity prior to administration.

    Altered Immunocompetence

    • May reduce immune responses in some individuals with altered immunocompetence, including those receiving immunosuppressant therapy.

    • Increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, Y and W-135, in persons with certain complement deficiencies and those receiving treatment that inhibits terminal complement activation (eg, eculizumab) even if they develop antibodies following vaccination with Menactra.

    Limitations of Vaccine Effectiveness

    • May not protect all recipients.

    Syncope

    • Syncope may occur. Procedures should be in place to avoid injury from fainting and manage syncopal reactions.

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Menactra during pregnancy. To enroll in or obtain information about the registry, call Sanofi Pasteur at 1-800-822-2463.

    Risk Summary

    • No adequate and well-controlled studies are available for Menactra administration in pregnant women in the US.

    • Available data suggest that rates of major birth defects (2–4%) and miscarriage (15–20%) in women who received Menactra 30 days prior to or during pregnancy are consistent with estimated background rates.

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Menactra and any potential adverse effects on the breastfed child from Menactra.

    Pediatric Considerations

    • Not approved for use in infants younger than 9 months of age.

    • Available data showed diminished responses to each meningococcal vaccine serogroup when infants received Menactra at 2, 4, and 6 months of age.

    Geriatric Considerations

    • Safety and efficacy has not been established in adults older than 55 years of age.

    Menactra Pharmacokinetics

    See Literature

    Menactra Interactions

    Interactions

    Immunosuppressants (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, high-dose steroids) may get suboptimal response. Concomitant vaccines: see full labeling.

    Interactions

    Concomitant Administration with Other Vaccines 

    • Children 4 through 6 years of age: When Menactra and Daptacel are administered together, give preference to simultaneous administration of both vaccines or administer Menactra before Daptacel. There has been reduced meningococcal antibody responses to Menactra when Menactra was given 1 month after Daptacel.

    • Prevnar (PCV7): Co-administration of Menactra with PCV7 has shown to decrease pneumococcal antibody response to some serotypes in PCV7.

    • Use different syringes and separate injection sites when Menactra is administered concomitantly with other injectable vaccines.

    Immunosuppressive Therapies

    • Immunosuppressants (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, high-dose steroids) may get suboptimal response. 

    Menactra Adverse Reactions

    Adverse Reactions

    Inj site reactions, headache, fatigue, malaise, arthralgia, vomiting, diarrhea, anorexia, chills, fever, rash, irritability, drowsiness; children: also, abnormal crying.

    Menactra Clinical Trials

    Clinical Trials

    Children 9 through 12 Months of Age

    • The approval was based on data from a randomized, multicenter US-trial which included children who received two doses of Menactra at 9 months and 12 months of age. The first Menactra dose was administered alone, followed by a second Menactra dose given alone, or with MMRV, or with PCV7. Sera was obtained approximately 30 days after the last vaccination for all participants. 

    • Findings showed that Menactra given 3 months apart elicited a robust immune response against the serogroups included in the vaccine. The studies also showed that the measles-mumps-rubella-varicella vaccine (MMRV) and pneumococcal conjugate vaccine (PCV7) can be administered concomitantly with Menactra in children.

    • Menactra was also evaluated when given to children at 12 months and 15 months of age. Prior to the first dose,  33.3% [n=16/48] of participants had a serum bactericidal assay with an exogenous human complement (SBA-H) titer ≥1:8 to Serogroup A, and 0-2% [n=0-1 of 50-51] to Serogroups C, Y and W-135. After the second dose, percentages of participants with an SBA-H titer ≥1:8 were: 85.2%, Serogroup A [n=46/54]; 100.0%, Serogroup C [n=54/54]; 96.3%, Serogroup Y [n=52/54]; 96.2%, Serogroup W-135 [n=50/52].

    Individuals 2 through 55 Years of Age 

    • Approval was based on three comparative, randomized, US, multicenter, active-controlled clinical trials that included children (2 through 10 years of age), adolescents (11 through 18 years of age), and adults (18 through 55 years of age).  Participants received a single dose of Menactra (N=2526) or Menomune – A/C/Y/W-135 (N=2317). For all age groups studied, sera were obtained before and approximately 28 days after vaccination.

    Immunogenicity in Children 2 through 10 Years of Age 

    • Of 1408 enrolled children 2 through 10 years of age, Menactra elicited comparable immune responses to Menomune A/C/Y/W-135 for all 4 serogroups.

    • In a subset of children 2 through 3 years of age with undetectable pre-vaccination titers, seroconversion rates were similar between Menactra and Menomune A/C/Y/W-135.

    • In a subset of children 4 through 10 years of age with undetectable pre-vaccination titers, seroconversion rates were similar between Menactra and Menomune A/C/Y/W-135.

    Immunogenicity in Adolescents 11 through 18 Years of Age 

    • In a comparative clinical trial, 881 adolescents 11 through 18 years of age showed similar immune responses for all 4 serogroups between Menactra and Menomune A/C/Y/W-135.

    • In participants with undetectable pre-vaccination titers, seroconversion rates were similar between Menactra and Menomune A/C/Y/W-135.

    Immunogenicity in Adults 18 through 55 Years of Age

    • In a comparative clinical trial, 2552 adults 18 through 55 years of age showed similar immune responses for all 4 serogroups between Menactra and Menomune A/C/Y/W-135.

    • In participants with undetectable pre-vaccination titers, seroconversion rates were similar between Menactra and Menomune A/C/Y/W-135.

    Immunogenicity in Adolescents and Adults Following Booster Vaccination

    • Prior to revaccination, the percentage of participants (n=781) with an SBA-H titer ≥1:8 were 64.5%, 44.2%, 38.7%, and 68.5% for Serogroups A, C, Y and W-135, respectively. Among the subset of trial participants (n=112) for whom SBA-H responses at Day 6 were assessed, 86.6%, 91.1%, 94.6%, and 92.0% achieved a ≥4-fold rise in SBA-H titer for Serogroups A, C, Y and W-135, respectively. The proportions of participants (n=781) who achieved a ≥4-fold rise in SBA-H titer by Day 28 were 95.0%, 95.3%, 97.1%, and 96% for Serogroups A, C, Y and W-135, respectively. The proportions of participants who achieved an SBA-H titer ≥1:8 by Day 28 were >99% for each serogroup.

    Menactra Note

    Notes

    To register pregnant patients or to report adverse events call (800) 822-2463. Refer to www.cdc.gov for ACIP guidelines on vaccinating acutely ill patients.

    Menactra Patient Counseling

    Patient Counseling

    Inform the patients, parents or guardians about: 

    • Potential benefits and risks of immunization with Menactra. 

    • Potential for adverse reactions that have been temporally associated with administration of Menactra or other vaccines containing similar components.

    • Reporting any adverse reactions to their healthcare provider. 

    • The Sanofi Pasteur Inc. Pregnancy Registry, as appropriate.

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