Type: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Form: Solution for injection
Dosage Form/Strength: 0.5 mL dose containing 4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier.
Manufacturer: Sanofi Pasteur Limited
Indications and Clinical Use
Purpose: Active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135.
Target Group: Persons 9 months through 55 years of age.
Contraindications
Hypersensitivity: Known systemic hypersensitivity reaction to any component of Menactra® or its container, or a life-threatening reaction after previous administration of a vaccine containing similar components.
Warnings and Precautions
General:
Inform recipients or their guardians about the benefits and risks of immunization.
Review the recipient’s health status, immunization history, and any possible hypersensitivity reactions.
Syncope (fainting) has been reported following vaccination.
Protection:
Menactra® only protects against N. meningitidis serogroups A, C, Y, and W-135, not against other microorganisms.
Not indicated for the prevention of invasive meningococcal disease caused by serogroup B or for the treatment of meningococcal infections.
Immunocompromised Individuals:
May not achieve the expected immune response.
Pregnant and Nursing Women:
Should be given to pregnant women only if clearly needed.
The effect on breast-fed infants is unknown; a risk-benefit assessment is necessary.
Neurological Disorders:
Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration.
Adverse Reactions
Very Common (>10%):
Injection site pain, induration, redness, and swelling.
Systemic reactions include headache, fatigue, malaise, and arthralgia.
Common (1-10%):
Fever, vomiting, diarrhea, anorexia, and rash.
Uncommon (<1%):
Serious allergic reactions, including anaphylaxis.
Seizures and thrombocytopenia.
Dosage and Administration
Recommended Dose:
Infants/Toddlers (9-23 months): Two doses of 0.5 mL, at least 3 months apart.
Persons (2-55 years): A single dose of 0.5 mL.
Administration: Intramuscular injection in the anterolateral aspect of the thigh for infants and in the deltoid muscle for older children, adolescents, and adults.
Storage and Stability
Storage Temperature: 2°C to 8°C (refrigeration).
Protection from Light: Store in the original package.
Do Not Freeze: Freezing destroys the vaccine.
Composition
Active Ingredients: 4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to diphtheria toxoid protein.
Excipients: Sodium chloride, sodium phosphate (dibasic and monobasic), water for injection.
Clinical Trials and Immunogenicity
Immunogenicity Studies:
Evaluated in infants, toddlers, children, adolescents, and adults.
Induces bactericidal antibodies specific to the capsular polysaccharides of serogroups A, C, Y, and W-135.
Achieved high seroprotection rates across various age groups.
Special Populations and Conditions
Pediatrics: Safe and effective in pediatric patients.
Geriatrics: Not evaluated in adults over 55 years.
Immunocompromised Individuals: Limited data; may not achieve expected immune response.
Post-Marketing Experience
Additional adverse events have been reported, including lymphadenopathy, hypersensitivity reactions, Guillain-Barré syndrome, and large injection site reactions.
