Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Indications

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine is used for: To prevent invasive, meningococcal disease

Adult Dose

Intramuscular injection Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Primary Vaccination: Individuals 2 through 55 years of age: A single (0.5 mL) 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.

Child Dose

Intramuscular injection Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Primary Vaccination: Children 9 through 23 months of age: Two doses, three months apart. Booster Vaccination: A single (0.5 mL) 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.

Renal Dose

Administration

Contra Indications

Severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM197- containing vaccine, or to any component of it.

Precautions

Guillain-Barré Syndrome Persons previously diagnosed with Guillain-Barré Syndrome (GBS) may be at increased risk of GBS following receipt of this vaccine. The decision to give this vaccine should take into account the potential benefits and risks. GBS has been reported in temporal relationships following the administration of this vaccine. Altered Immunocompetence Reduced Immune Response Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to this vaccine. Complement Deficiency Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, Y and W-135, even if they develop antibodies following vaccination with this vaccine. Syncope Syncope (fainting) has been reported following vaccination with this vaccine. Procedures should be in place to prevent falling injuries and manage syncopal reactions.

Pregnancy-Lactation

Risk Summary All pregnancies have a risk of birth defects, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Lactation Risk Summary The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this vaccine and any potential adverse effects on the breastfed child from the vaccine. Data are not available to assess the effects of Menactra on the breastfed infant or on milk production/excretion.

Interactions

When Menactra and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed are to be administered to children 4 through 6 years of age, preference should be given to simultaneous administration of the 2 vaccines or administration of Menactra prior to DAPTACEL. Administration of Menactra one month after DAPTACEL has been shown to reduce meningococcal antibody responses to Menactra. Pneumococcal antibody responses to some serotypes in Prevnar (PCV7) were decreased following the co-administration of Menactra and PCV7.

Adverse Effects

Side effects of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine : >10% 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% 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%)

Mechanism of Action

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