Type: Meningococcal (Groups A, C, W-135, and Y) Polysaccharide Conjugate Vaccine
Form: Powder and diluent for solution for injection
Dosage Form/Strength: 0.5 mL dose containing:
Meningococcal group A polysaccharide 5 mcg conjugated to tetanus toxoid protein 44 mcg
Meningococcal group C polysaccharide 5 mcg conjugated to tetanus toxoid protein 44 mcg
Meningococcal group W-135 polysaccharide 5 mcg conjugated to tetanus toxoid protein 44 mcg
Meningococcal group Y polysaccharide 5 mcg conjugated to tetanus toxoid protein 44 mcg
Manufacturer: Pfizer Canada ULC
Indications and Clinical Use
Purpose: Active immunization against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y.
Target Group: Individuals from 6 weeks to 55 years of age.
Contraindications
Hypersensitivity: Known hypersensitivity to any component of NIMENRIX® or any diphtheria toxoid-containing vaccine.
Warnings and Precautions
General:
Ensure medical treatment for anaphylactic reactions is available.
Not to be injected intravenously, subcutaneously, or intradermally.
Review patient’s medical history for contraindications.
May not protect against all strains of meningococcal disease.
Special Populations:
Pregnant Women: Limited data available; use only if benefits outweigh risks.
Nursing Women: Unknown if excreted in human milk; use only if benefits outweigh risks.
Immunocompromised Individuals: May not achieve the expected immune response.
Infants and Children: Safe and effective from 6 weeks of age.
Geriatrics: Limited data available for individuals aged 56 years and older.
Dosage and Administration
Primary Immunization:
Infants (6 weeks to <6 months): Two doses of 0.5 mL, 2 months apart.
Unvaccinated infants (6 to <12 months): One dose of 0.5 mL followed by a booster at 12 months.
Children (12 months and older), Adolescents, and Adults: One dose of 0.5 mL.
Booster Dose: Can be given to individuals who have previously received primary vaccination with NIMENRIX® or other meningococcal vaccines.
Administration: Intramuscular injection, preferably in the anterolateral thigh (infants) or deltoid muscle (older children, adolescents, adults).
Reconstitution and Handling
Reconstitution: Add the entire content of the pre-filled syringe of diluent to the vial containing the powder. Shake well until the powder is completely dissolved. Use promptly after reconstitution.
Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Protect from light.
Adverse Reactions
Very Common (>10%):
Injection site reactions: pain, redness, swelling
General symptoms: irritability, drowsiness, loss of appetite, fever
Common (1-10%):
Gastrointestinal symptoms: diarrhea, vomiting
General symptoms: headache, malaise, fatigue, myalgia, arthralgia
Uncommon (<1%):
Serious allergic reactions, including anaphylaxis
Seizures, thrombocytopenia
Clinical Trials
Immunogenicity:
Demonstrated high seroprotection rates against groups A, C, W-135, and Y in various age groups.
Studies conducted in infants, toddlers, children, adolescents, and adults.
Safety:
Extensive clinical trials with over 10,000 subjects vaccinated.
Common adverse reactions included injection site pain, irritability, drowsiness, and fever.
Drug Interactions
Concomitant Vaccinations:
Can be administered with other vaccines such as DTaP/IPV/Hib/HepB, PCV10, MMR, MMRV, HAV, HBV, unadjuvanted seasonal influenza vaccine, and HPV2.
Separate injection sites should be used when administered with other injectable vaccines.
Special Handling Instructions
No special handling instructions. Follow standard procedures for vaccine administration.
