Type: Meningococcal (Groups A, C, W-135, and Y) Oligosaccharide CRM197 Conjugate Vaccine
Form: Powder and solution for injection
Dosage Form/Strength: 0.5 mL dose containing:
Meningococcal group A oligosaccharide 10 µg conjugated to CRM197 protein 16.7-33.3 µg
Meningococcal group C oligosaccharide 5 µg conjugated to CRM197 protein 7.1-12.5 µg
Meningococcal group W-135 oligosaccharide 5 µg conjugated to CRM197 protein 3.3-8.3 µg
Meningococcal group Y oligosaccharide 5 µg conjugated to CRM197 protein 5.6-10 µg
Manufacturer: GlaxoSmithKline Inc.
Indications and Clinical Use
Purpose: Active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135, and Y.
Target Group: Individuals 2 months through 55 years of age.
Contraindications
Hypersensitivity: Known hypersensitivity to any component of MENVEO, including CRM197 or other diphtheria-containing vaccines, or a life-threatening reaction after previous administration of a vaccine containing similar components.
Warnings and Precautions
General:
Ensure medical treatment for anaphylactic reactions is available.
Review the patient’s immunization and medical history for contraindications.
Anxiety-related reactions, such as syncope and hyperventilation, may occur.
Immune Response:
Immunocompromised individuals may have an inadequate response.
Not evaluated in individuals receiving treatment that inhibits terminal complement activation.
Special Populations:
Pregnant Women: Use only if benefits outweigh risks.
Nursing Women: Unknown if excreted in human milk; a risk-benefit assessment is necessary.
Pediatrics: Safety and effectiveness not established in children under 2 months.
Geriatrics: Safety and immunogenicity not established in adults 56 years and older.
Adverse Reactions
Very Common (>10%):
Injection site reactions: tenderness, erythema, induration.
Systemic reactions: irritability, sleepiness, persistent crying, change in eating habits, vomiting, diarrhea in infants.
Common (1-10%):
Fever, headache, malaise, nausea, arthralgia, myalgia in adolescents and adults.
Rare (<1%):
Serious allergic reactions, including anaphylaxis, seizures, thrombocytopenia.
Clinical Trials
Immunogenicity Studies:
Evaluated in infants, toddlers, children, adolescents, and adults.
Induces bactericidal antibodies against serogroups A, C, W-135, and Y.
Achieved high seroprotection rates across various age groups.
Dosage and Administration
Primary Immunization:
Infants (2-6 months): 3 doses at 2-month intervals, followed by a fourth dose at 12-16 months.
Infants and Toddlers (7-23 months): 2 doses at least 2 months apart.
Individuals 2 years and older: A single 0.5 mL dose.
Administration: Intramuscular injection in the anterolateral aspect of the thigh (infants) or the deltoid muscle (older children, adolescents, adults).
Storage and Stability
Storage Temperature: 2°C to 8°C (refrigeration).
Stability: Use immediately after reconstitution; may be held at or below 25°C for up to 2 hours.
Shelf Life: Do not use after the expiry date.
Special Handling: Do not freeze. Protect from light.
Composition
Active Ingredients: Meningococcal A, C, W-135, and Y oligosaccharides conjugated to CRM197 protein.
Excipients: Potassium dihydrogen phosphate, sodium chloride, sodium phosphate buffer, sucrose, water for injection.
No preservative or adjuvant: The vaccine contains no thimerosal, and container closures are latex-free.
Packaging
Pack Sizes: 1 dose (2 vials), 5 doses (10 vials), or 10 doses (20 vials) per package.
Post-Marketing Experience
Reports include ear pain, vertigo, injection site pruritus, erythema, hypersensitivity reactions, syncope, and others.
