Anti-capsular meningococcal antibodies protect against meningococcal diseases via complement mediated bactericidal activity. Meningococcal Conjugate Vaccine induces the production of bactericidal antibodies against capsular polysaccharides of Neisseria meningitidis group A,C,W-135 and Y when measured by assays using either rSBA or hSBA.

After reconstitution, 1 dose (0.5 ml) contains:

• Neisseria meningitidis group A polysaccharide 1 5 micrograms
• Neisseria meningitidis group C polysaccharide 1 5 micrograms
• Neisseria meningitidis group W-135 polysaccharide 1 5 micrograms
• Neisseria meningitidis group Y polysaccharide 1 5 micrograms

Meningococcal Conjugate Vaccine is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.

Posology: Meningococcal Conjugate Vaccine should be used in accordance with available official recommendations. Primary immunisation:

• Infants from 6 weeks to less than 6 months of age: two doses, each of 0.5 ml, should be administered with an interval of 2 months between doses.
• Infants from 6 months of age, children, adolescents and adults: a single 0.5 mL doseshould be administered.
• An additional primary dose of Meningococcal Conjugate Vaccine may be considered appropriate for some individuals.

Booster doses: After completion of the primary immunisation course in infants 6 weeks to less than 12 months of age, a booster dose should be given at 12 months of age with an interval of at least 2 months after the last Meningococcal Conjugate vaccination. In previously vaccinated individuals 12 months of age and older, Meningococcal Conjugate Vaccine may be given as a booster dose if they have received primary vaccination with a conjugated or plain polysaccharide meningococcal vaccine.

Administration

Immunisation should be carried out by intramuscular injection only. In infants, the recommended injection site is the anterolateral aspect of the thigh. In individuals from 1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. For instructions on reconstitution of the medicinal product before administration.

Hypersensitivity to the active substances or to any of the excipients of this preparation.

Adverse reactions are Appetite lost, Irritability, Insomnia, Crying, Drowsiness, Headache, Hypoaesthesia, Dizziness, Diarrhoea, Vomiting, Nausea, Pruritus, Rash, Myalgia, Pain in extremity, Fever, Swelling at injection site, Pain at injection site, Redness at injection site, Fatigue, Injection site haematoma, Malaise, Injection site induration, Injection site pruritus, Injection site warmth, Injection site anaesthesia

Overdose Effects

No case of overdose has been reported.

Pregnancy: There is limited experience with use of Meningococcal Conjugate Vaccine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Meningococcal Conjugate Vaccine should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.

Breast-feeding: It is unknown whether Meningococcal Conjugate Vaccine is excreted in human milk. Meningococcal Conjugate Vaccine should only be used during breast-feeding when the possible advantages outweigh the potential risks.