Prevenar 13, 0.5 ml/dose 0.5 ml

Prevenar is a vaccine for the prevention of pneumococcal infections. It contains 7 active substances, which are pneumococcal polysaccharides derived from Gram-positive bacteria Streptococcus pneumoniae, individually conjugated with diphtheria carrier protein CRM197, and adsorbed on aluminum phosphate.

The administration of the Prevenar vaccine induces the production of antibodies to the capsular polysaccharides of Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, providing specific protection against infections caused by them.

Immunological efficacy

In children of the first year of life, starting at the age of 2 months, using different vaccination regimens, the formation of a protective immune response was demonstrated after a series of primary vaccinations and a secondary immune response to the last dose, i.e. at revaccination. After administration of 3 doses at primary vaccination and subsequent revaccination, a significant rise in antibody levels was observed. Prevenar induces formation of functional antibodies to all serotypes of the vaccine.

In children aged 2 to 5 years, pronounced formation of antibodies to all serotypes of the vaccine was observed after a single administration of Prevenar, and the immune response was almost identical to that in children of the first 2 years of life after the series of primary immunizations.

Efficacy in the prevention of infectious diseases

. A large-scale clinical study of the efficacy of Prevenar immunization in the United States, which included more than 18,000 children aged 2, 4, 6, and 12-15 months, showed that the specific efficacy of the vaccine to prevent invasive pneumococcal disease (IPD) was 97%, with coverage of 85% of these diseases in children in the US and slightly less in European countries (65-80%).

Efficacy in preventing pneumonia

The prophylactic efficacy of Prevenar against bacterial pneumonia caused by vaccine-like Streptococcus pneumoniae serotypes was 87.5%.

The efficacy in the prevention of acute otitis media

The efficacy of Prevenar in children aged 2, 4, 6 and 12-15 months against acute otitis media (otitis media) caused by pneumococcal serotypes included in the vaccine is about 54%.

The incidence of OSA caused by serotypes not included in the vaccine was 33% higher among immunized children. Nevertheless, the overall positive preventive effect was a 34% reduction in the incidence of pneumococcal OSA. The overall reduction in cases of otitis media without regard to etiology was 6%. Prevenar was shown to be 18% effective in preventing frequent otitis media (at least 3 exacerbations within 6 months), 9% effective for recurrent otitis media (3 exacerbations within 6 months or 4 times a year) and 23% effective for otitis media with 5 recurrences within 6 months or 6 times a year and 50% effective for exudative chronic otitis media. The need for a tympanostomy in Prevenar-vaccinated children was reduced by 24% to 39%.

Indications

Prevention of diseases caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteremia and acute otitis media) in children aged 2 months to 5 years.

Active ingredient

Vaccine to prevent pneumococcal infections

Composition

Active ingredients:

Pneumococcal conjugates (polysaccharide + CRM197):

Polysaccharide serotype 4 2 µg;

Polysaccharide serotype 6B 4 µg;

Polysaccharide of serotype 9V2 µg;

Polysaccharide of serotype 142 µg;

serotype 18C oligosaccharide 2 µg;

Polysaccharide serotype 19F 2 µg;

serotype 23F polysaccharide 2 µg;

The carrier protein CRM 197″20 µg;

Auxiliary substances:

aluminum phosphate;

sodium chloride;

water for injection;

How to take, the dosage

Intramuscularly only, into the anterolateral surface of the thigh (children under 2 years of age) or into the deltoid muscle of the shoulder (children over 2 years of age). Do not give Prevenar intravenously!

Before applying the Prevenar vaccine, shake the contents of the syringe until a homogeneous suspension is obtained. Do not use if the examination of the contents of the syringe reveals foreign particles or if the contents are not a homogeneous suspension of white color. White cloudy residue is acceptable.

Patient vaccination schedule

At the age of 2 to 6 months, three doses of vaccine at 0.5 ml each, with an interval between doses of at least 1 month, the first dose is usually administered at the age of 2 months. The fourth dose (i.e. revaccination) is recommended in the second year of life, optimally at 12-15 months of age.

For children who have not been vaccinated in the 1st half of life, Prevenar is administered according to the schemes:

From 7 to 11 months of age, 2 doses of 0.5 mL each, with at least 1 month interval between injections. A third dose (i.e. revaccination) is recommended in the second year of life.

At the age of 12 to 23 months, 2 doses of 0.5 ml each, with an interval of at least 2 months between injections.

In the age of 2 to 5 years, 1 dose of 0.5 ml once.

The need for any additional dose after each of the above immunization regimens has not been determined.

Interaction

Prevenar can be administered to children simultaneously (on the same day) with other vaccines included in the National Preventive Immunization Calendar (except BCG), as well as with Hib vaccine and Infanrix hexavalent vaccine, according to the prescribed immunization schedule.

The vaccines must always be administered in different parts of the body.

Contraindications

• acute infectious and noninfectious diseases, exacerbation of chronic diseases (in these cases, the vaccination is carried out after recovery or in remission);
• high sensitivity to the previous administration of Prevenar;
• high sensitivity to excipients and/or diphtheria anatoxin.

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Side effects

Local reactions: very common – redness, thickening/swelling, pain/pain); common – swelling/swelling of the injection site and redness greater than 2.4 cm, pain at the injection site, leading to short-term limb limitation of movement; rare – allergic reactions at the injection site (dermatitis, itching, urticaria).

General reactions: very common – hyperthermia 38°C or higher (measured per rectum), irritability, drowsiness, restless sleep, tearfulness; common – hyperthermia > 39°C (measured per rectum); rarely – episodes of arterial hypotension, hyporeactivity.

Allergic reactions: rare – hypersensitivity reactions, including anaphylactic shock, angioedema, Quincke’s edema, bronchospasm, dyspnea.

CNS disorders: rarely – seizures, including febrile seizures.

Digestive system disorders: very often – vomiting, diarrhea, decreased appetite.

Dermatological reactions: sometimes – urticaria; very rarely – erythema multiforme.

Others: very rare – regional lymphadenopathy.