Menactra
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Labeling Changes
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Uses
Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by N meningitidis serogroups A, C, Y and W-135. Menactra vaccine is approved for use in individuals 9 months through 55 years of age. Menactra vaccine does not prevent N meningitidis serogroup B disease.
History
There is currently no drug history available for this drug.
Other Information
Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is a sterile, intramuscularly administered vaccine that contains Neisseria meningitidis serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein. N meningitidis A, C, Y and W-135 strains are cultured on Mueller Hinton agar (3) and grown in Watson Scherp (4) media containing casamino acid. The polysaccharides are extracted from the N meningitidis cells and purified by centrifugation, detergent precipitation, alcohol precipitation, solvent extraction and diafiltration. To prepare the polysaccharides for conjugation, they are depolymerized, derivatized, and purified by diafiltration. Diphtheria toxin is derived from Corynebacterium diphtheriae grown in modified culture medium containing hydrolyzed casein (5) and is detoxified using formaldehyde. The diphtheria toxoid protein is purified by ammonium sulfate fractionation and diafiltration. The derivatized polysaccharides are covalently linked to diphtheria toxoid and purified by serial diafiltration. The four meningococcal components, present as individual serogroup-specific glycoconjugates, compose the final formulated vaccine. No preservative or adjuvant is added during manufacture. Each 0.5 mL dose may contain residual amounts of formaldehyde of less than 2.66 mcg (0.000532%), by calculation. Potency of Menactra vaccine is determined by quantifying the amount of each polysaccharide antigen that is conjugated to diphtheria toxoid protein and the amount of unconjugated polysaccharide present.
Menactra vaccine is manufactured as a sterile, clear to slightly turbid liquid. Each 0.5 mL dose of vaccine is formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg each of meningococcal A, C, Y and W-135 polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier.
The vial stopper is not made with natural rubber latex.
Sources
Menactra Manufacturers
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Remedyrepack Inc.
![Menactra (Neisseria Meningitidis Group A Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen) Injection, Solution [Remedyrepack Inc. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Menactra | Remedyrepack Inc.
A 0.5 mL dose for intramuscular injection. (2)
Primary Vaccination:
Children 9 through 23 months of age: Two doses, three months apart. Individuals 2 through 55 years of age: A single dose.Booster Vaccination:
A single booster dose may be given to individuals 15 through 55 years of age at continued risk for meningococcal disease, if at least 4 years have elapsed since the prior dose.Menactra vaccine is a clear to slightly turbid solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exist, the vaccine should not be administered.
Withdraw the 0.5 mL dose of vaccine from the single-dose vial using a sterile needle and syringe.
Menactra vaccine is administered as a 0.5 mL dose by intramuscular injection. Do not administer this product intravenously or subcutaneously.
Primary Vaccination:
In children 9 through 23 months of age, Menactra vaccine is given as a 2-dose series three months apart. Individuals 2 through 55 years of age, Menactra vaccine is given as a single dose.Booster Vaccination:
A single booster dose may be given to individuals 15 through 55 years of age at continued risk for meningococcal disease, if at least 4 years have elapsed since the prior dose. -
Sanofi Pasteur Inc.
Menactra | Sanofi Pasteur Inc.
2.1 Preparation for AdministrationMenactra vaccine is a clear to slightly turbid solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exist, the vaccine should not be administered.
Withdraw the 0.5 mL dose of vaccine from the single-dose vial using a sterile needle and syringe.
2.2 Dose and ScheduleMenactra vaccine is administered as a 0.5 mL dose by intramuscular injection. Do not administer this product intravenously or subcutaneously.
Primary Vaccination:
In children 9 through 23 months of age, Menactra vaccine is given as a 2-dose series three months apart. Individuals 2 through 55 years of age, Menactra vaccine is given as a single dose.Booster Vaccination:
A single booster dose may be given to individuals 15 through 55 years of age at continued risk for meningococcal disease, if at least 4 years have elapsed since the prior dose.
![Menactra (Neisseria Meningitidis Group A Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen, And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Diphtheria Toxoid Conjugate Antigen) Injection, Solution [Sanofi Pasteur Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4d8781ff-9366-462c-8161-6e958f44fcb4&name=menactra-01.jpg)
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