NeisVac-C®

Product Overview

• Brand Name: NeisVac-C® Vaccine
• Type: Meningococcal Group C-TT Conjugate Vaccine, Adsorbed
• Form: Suspension for injection
• Dosage Form/Strength: 0.5 mL dose containing 10 mcg Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid protein.

Indications and Clinical Use

• Purpose: Active immunization for the prevention of meningitis and/or septicemia caused by Neisseria meningitidis serogroup C.
• Target Group:
  • Pediatrics: Authorized for use in children from 2 months of age.
  • Adolescents and Adults: Authorized for use in adolescents and adults.
  • Geriatrics: Studies have not been conducted in adults 65 years or older.

Contraindications

• Known or suspected hypersensitivity to NeisVac-C® vaccine or any of its components, including tetanus toxoid.

Warnings and Precautions

• General:
  • Not to be injected intravenously or subcutaneously.
  • Adequate medical treatment should be available for anaphylactic reactions.
  • Postpone administration in individuals with acute severe febrile illness.
  • Does not protect against other serogroups of Neisseria meningitidis or other organisms causing meningitis or septicemia.
• Special Populations:
  • Pregnant Women: Use only if clearly needed, as safety during pregnancy and lactation has not been established.
  • Breast-feeding: Risk/benefit assessment required.
  • Pediatrics: Safe and effective in pediatric patients.
  • Geriatrics: No data in adults 65 years or older.
• Other Warnings:
  • Clinical vigilance for meningitis is necessary as the vaccine does not cause meningococcal C meningitis.
  • Exercise caution in individuals with thrombocytopenia or bleeding disorders.
  • May not induce protective antibody levels in immunocompromised individuals.

Dosage and Administration

• Primary Immunization:
  • Infants (2-4 months): Two doses of 0.5 mL with at least 2 months interval.
  • Infants (4 months and older), Children, Adolescents, Adults: One dose of 0.5 mL.
• Booster Doses: For infants who completed primary immunization, a booster dose at 12-13 months of age.
• Administration: Intramuscular injection, preferably in the anterolateral thigh (infants) or deltoid region (older children, adolescents, adults).
• Preparation: Shake well before use to obtain a homogenous suspension; inspect for foreign matter or discoloration.

Adverse Reactions

• Very Common (>10%):
  • Injection site reactions (pain, redness, swelling).
  • Headache, fever.
  • Irritability, drowsiness, sleepiness, impaired sleeping in infants.
  • Decreased appetite, vomiting, diarrhea in infants.
• Common (1-10%):
  • Muscle pain, pains in the arms or legs.
  • Sleep disorder, fatigue.
• Rare (<1%):
  • Serious allergic reactions (swelling, rash, anaphylaxis).
  • Severe skin rashes, Stevens-Johnson syndrome.
  • Fits/seizures.

Clinical Trials

• Immunogenicity: Highly immunogenic across various age groups, inducing strong serum bactericidal activity (SBA) against meningococcal strain C11.
  • Infants (2 months): 100% achieved SBA titre of at least 1/8 after one dose.
  • Toddlers (12-17 months): 100% developed SBA titres of at least 1/8 after one dose.
  • Children (3.5-6 years): 98.6% achieved SBA titres of at least 1/32.
  • Adolescents (13-17 years): 100% achieved SBA titres of at least 1/32.
  • Adults (18-46 years): 100% achieved SBA titres of at least 1/32.

Storage and Stability

• Storage Temperature: +2°C to +8°C (refrigeration).
• Stability: May be stored at room temperature (up to +25°C) for a single period not exceeding 9 months.
• Shelf Life: Use before expiration date printed on the label.
• Special Handling: Shake well before use, inspect visually for foreign matter or discoloration.

Composition

• Active Ingredient: Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid protein.
• Non-Medicinal Ingredients: Aluminium hydroxide, sodium chloride, water for injection.