Type: Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine
Form: Solution for injection
Dosage Form/Strength: 0.5 mL dose containing:
Meningococcal group A polysaccharide 10 mcg conjugated to tetanus toxoid protein
Meningococcal group C polysaccharide 10 mcg conjugated to tetanus toxoid protein
Meningococcal group W polysaccharide 10 mcg conjugated to tetanus toxoid protein
Meningococcal group Y polysaccharide 10 mcg conjugated to tetanus toxoid protein
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, W, and Y.
Target Group: Individuals 12 months of age and older.
Limitation: Does not prevent disease caused by serogroup B.
Contraindications
Hypersensitivity: Known hypersensitivity to any component of MenQuadfi, including tetanus toxoid, or after a previous administration of the vaccine.
Dosage and Administration
Primary Vaccination:
Individuals 12 months and older: A single dose of 0.5 mL.
Booster Vaccination:
Adolescents and adults at continued risk may receive a booster dose if at least 4 years have elapsed since the previous dose.
Administration: Intramuscular injection into the deltoid region or anterolateral thigh. Inspect visually for particulate matter or discoloration before administration.
Storage and Stability
Storage Temperature: 2°C to 8°C (refrigeration).
Protection: Do not freeze; protect from light.
Shelf Life: Do not use after the expiration date on the label.
Warnings and Precautions
General:
Postpone vaccination in individuals with acute severe febrile illness.
Medical treatment should be readily available for anaphylactic reactions.
Special Populations:
Pregnant Women: Use only if the potential benefits outweigh the risks.
Breastfeeding: No data available; use only if the benefits outweigh the risks.
Pediatrics (<12 months): Safety and immunogenicity not established.
Geriatrics (≥65 years): Safety and immunogenicity established.
Other Considerations:
Vaccination may not protect all recipients.
Administer with caution to individuals with thrombocytopenia or coagulation disorders.
Syncope can occur following vaccination; procedures should be in place to prevent injury.
Adverse Reactions
Very Common (≥10%):
Injection site pain, erythema, and swelling.
Systemic reactions include myalgia, headache, malaise, and fever.
Common (1-10%):
Gastrointestinal symptoms such as nausea and vomiting.
Fatigue, arthralgia, and rash.
Uncommon (<1%):
Serious allergic reactions including anaphylaxis.
Neurological symptoms such as seizures and Guillain-Barré syndrome.
Clinical Trials and Immunogenicity
Pivotal Studies:
Evaluated in individuals 12 months and older across multiple clinical trials.
Immunogenicity:
High seroprotection rates observed for all serogroups (A, C, W, Y).
Demonstrated non-inferiority to comparator vaccines in various age groups.
Safety:
Extensive trials with over 5,327 participants receiving MenQuadfi.
Common adverse reactions include injection site pain, erythema, and systemic symptoms like headache and fatigue.
Drug Interactions
Concomitant Vaccinations:
Can be administered with other vaccines, but use separate injection sites.
No established serological correlates of protection for pertussis when co-administered with Tdap and HPV vaccines.
