MENJUGATE

Product Overview

• Brand Name: MENJUGATE Liquid
• Type: Meningococcal Group C Conjugate Vaccine
• Form: Suspension for injection
• Dosage Form/Strength: 0.5 mL dose containing 10 mcg Meningococcal Group C Oligosaccharide conjugated to CRM197 protein.

Indications and Clinical Use

• Purpose: Active immunization of children from 2 months of age, adolescents, and adults for the prevention of invasive disease caused by Neisseria meningitidis serogroup C.
• Target Group: Infants from 2 months of age, older children, adolescents, and adults.

Contraindications

• Known hypersensitivity to any component of the vaccine, including diphtheria toxoid (CRM197).
• Administration should be postponed in individuals with acute severe febrile illness.

Warnings and Precautions

• General:
  • Ensure availability of medical treatment for anaphylactic reactions.
  • Prior to administration, review personal history, family history, recent health status, immunization history, and any adverse events associated with previous immunizations.
  • The vaccine does not protect against other serogroups of meningococcal bacteria (A, B, 29-E, H, I, K, L, W-135, X, Y, or Z).
  • MENJUGATE should not be injected intravenously, subcutaneously, or intradermally.
• Special Populations:
  • Not evaluated in persons with thrombocytopenia or other bleeding disorders.
  • May not result in appropriate protective antibody response in individuals deficient in antibody production.
  • Not specifically evaluated in immunocompromised populations such as HIV-infected individuals.
• Pregnancy and Lactation:
  • Animal studies do not indicate direct or indirect harmful effects.
  • Should not be used during pregnancy unless clearly needed.
  • The effect on breast-fed infants is unknown; a risk-benefit assessment is necessary.

Adverse Reactions

• Very Common (>10%):
  • Injection site pain, erythema, swelling.
  • Irritability, change in appetite, diarrhea, fever in younger children.
• Common (1-10%):
  • Fever, headache, malaise, nausea, arthralgia, myalgia in adolescents and adults.
  • Crying, irritability, drowsiness, impaired sleeping, anorexia, diarrhea, vomiting in infants and young children.
• Uncommon (0.1-1%):
  • Dizziness, chills, rash, nausea, vomiting, diarrhea in various age groups.
• Rare (<0.1%):
  • Seizures, anaphylaxis, lymphadenopathy, rash, urticaria, myalgia, arthralgia.

Clinical Trials

• Immunogenicity:
  • Highly immunogenic, inducing protective levels of bactericidal antibodies in a significant number of subjects.
  • Superior immune response compared to licensed unconjugated polysaccharide vaccines in children from 12 months of age.
  • Induces immunologic memory in infants and children from 12 months of age.

Dosage and Administration

• Primary Immunization:
• Infants (2-12 months): 3 doses of 0.5 mL each, with at least 1-month intervals between doses.
• Children >12 months, Adolescents, and Adults: A single 0.5 mL dose.
• Booster Doses: Recommended after the primary immunization series in infants; timing according to NACI recommendations.
• Administration:
  • Intramuscular injection only, preferably in the anterolateral thigh in infants and in the deltoid region in older children, adolescents, and adults.
  • Do not mix with other vaccines in the same syringe; separate injection sites should be used if administering multiple vaccines simultaneously.

Storage and Stability

• Store at +2°C to +8°C (refrigeration).
• Do not freeze.
• Protect from light.
• Shelf life of 36 months.

Composition

• Each 0.5 mL dose contains:
• 10 mcg Neisseria meningitidis group C oligosaccharide conjugated to CRM197 protein (12.5 to 25 mcg).
• Excipients: aluminium hydroxide (1 mg), histidine (0.78 mg), sodium chloride (4.5 mg), water for injection.
• Packaging: Available in single-dose vials or prefilled syringes (0.5 mL dose).

Consumer Information

• Use: Prevention of diseases caused by Neisseria meningitidis serogroup C in infants, children, adolescents, and adults.
• Administration: Given by healthcare professionals via intramuscular injection.
• Side Effects: Common side effects include injection site reactions, irritability, fever, headache, and muscle pain. Serious allergic reactions are rare.

For more detailed information, refer to the full product monograph.