Active immunization of children after the completion of 2 exercises, adolescents and adults against infections caused byNeisseria meningitidis group C.
Composition:
1 dose (0.5 ml) contains 10 μg of polysaccharideNeisseria meningitidis C (strain C 11) conjugated with 10-20 μg of tetanus toxoid and adsorbed to aluminum hydroxide.
Action:
Meningococcal vaccine. The clinical efficacy of the vaccine has not been tested. Research is ongoing to determine the correlation of serological response and clinical efficacy. Data on the response expressed as oily bactericidal antibodies indicate the appropriateness of administering 2 doses of vaccine to infants and one dose to children over 1 year of age, adolescents and adults. The estimates of vaccine efficacy (post-marketing monitoring) have demonstrated the need for a booster dose after completing the primary course of vaccination in infants. In addition, efficacy data, based on a small number of cases, indicate that immunity may also decrease in children who are vaccinated with a single dose of the vaccine at 12-24 months of age. Efficacy in other age groups (up to 18 years) vaccinated with a single dose is around 90% or more, after more than one year after vaccination.
Contraindications:
Hypersensitivity to the components of the vaccine, including tetanus toxoid. acute infection or illness with fever (vaccination should be postponed). Do not administer intravenously or subcutaneously.
Precautions:
Particular care should be taken in preterm infants born ≤ 28 weeks of pregnancy, especially those who had symptoms of immaturity of the respiratory system (the risk of apnea should be taken into account and the need to monitor respiratory function for 48-72 h); Due to the significant benefits of vaccinating this group of infants, vaccination should not be abandoned or postponed. Use with caution in patients with thrombocytopenia or other coagulation disorders. In patients with known immunodeficiency or immunosuppressive therapy, the response to vaccination may be reduced. It is thought that in patients with deficiency of complement and in patients with anatomical or functional lack of spleen it is possible to obtain an immune response after administration of conjugated meningococcal vaccines (the degree of protection against infection is unknown). There are no data on the use of the vaccine in patients over 65 years. The vaccine does not protect against infections caused by meningococci of other groups, or against other microorganisms that cause meningitis and sepsis. There are no data on the use of the drug to stop the development of the disease. The incidence of vaccination is not a substitute for routine tetanus vaccination.
Pregnancy and lactation:
Pregnancy should not be a contraindication for vaccination in case of a clear risk of infection. During breastfeeding, vaccination can be carried out when the expected benefit to the mother outweighs the potential risk to the child.
Side effects:
Very common: reactions at the injection site (redness, sensitivity to touch, pain and swelling); pain in the limbs in older children; Headache; in infants and infants - crying and irritability, lethargy, drowsiness, difficult falling asleep; in infants - vomiting, nausea, diarrhea and loss of appetite. Common: fever; in children - loss of appetite, vomiting, nausea, diarrhea; muscle pain in older children and adults; pain in the limbs in children. In addition, after the marketing, the following side effects were observed: lymphadenopathy, idiopathic thrombocytopenic purpura, anaphylactic reaction, hypersensitivity reactions (bronchospasm, facial edema, angioneurotic edema), dizziness, convulsions, including feverish, syncope, hypoesthesia and paraesthesia, in infants - reduced muscle tone; rash, urticaria, pruritus, arthralgia, premature babies ≤ 28th week of pregnancy - apnea. Very rare: epileptic seizures, ecchymosis, purpura.There was also a Stevens-Johnson syndrome, erythema multiforme, recurrences of nephrotic syndrome due to administration of vaccines that were cured against meningococcal group C.
Dosage:
Intramuscular (infants: anterolateral thigh area, older children, adolescents and adults: shoulder muscle).Basic vaccination. Infants from 3 months up to 12 months: 2 doses with at least a two-month interval between each dose. Children over 12 months, adolescents and adults: 1 dose.Revaccination. After completing the primary immunization cycle in infants, a booster dose is recommended (timing according to official recommendations). It has not been established whether a booster dose is needed for people who have received the first dose at the age of 12 months or later. Whenever possible, the same vaccine should be used throughout the vaccination course.
(C)
