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.

Pharmacological effect

Prevenar is a vaccine for the prevention of pneumococcal infections. Contains 7 active substances, which are pneumococcal polysaccharides obtained from the gram-positive bacteria Streptococcus pneumoniae, individually conjugated to the diphtheria carrier protein CRM197, and adsorbed on aluminum phosphate.

Administration of the Prevenar vaccine causes the production of antibodies to capsular polysaccharides of Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, providing specific protection of the body against the infections they cause.

Immunological effectiveness

In children of the first year of life, starting from the age of 2 months, using various 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. during revaccination. After 3 doses of primary vaccination and subsequent revaccination, a significant increase in antibody levels was observed. Prevenar induces the formation of functional antibodies to all vaccine serotypes.

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

Efficacy in preventing infectious diseases

In a large-scale clinical study of the effectiveness of immunization with Prevenar, conducted in the United States, which included more than 18,000 children aged 2, 4, 6 and 12-15 months, it was shown that the specific effectiveness of the vaccine for the prevention of invasive diseases of pneumococcal origin (IDD) was 97%, with coverage of 85% of these diseases in children in the United States and slightly less in European countries (65-80%).

Efficacy in preventing pneumonia

The effectiveness of the prophylactic administration of Prevenar against bacterial pneumonia caused by Streptococcus pneumoniae serotypes similar to the vaccine was 87.5%.

Efficacy in the prevention of acute otitis media

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

Among immunized children, the incidence of AOM due to serotypes not included in the vaccine was 33% higher. However, the overall positive preventive effect was expressed in a reduction in the incidence of pneumococcal AOM by 34%. The overall reduction in the number of cases of otitis media without regard to etiology was 6%. It was shown that the effectiveness of Prevenar in the prevention of frequent otitis media (at least 3 exacerbations of the disease within 6 months) was 18%, with recurrent AOM (3 exacerbations in 6 months or 4 times a year) – 9% and 23% in AOM with relapses 5 times in 6 months or 6 times a year, and 50% in exudative chronic otitis media. The need for tympanostomy in children vaccinated with Prevenar decreased by 24-39%.

Active ingredient

Vaccine for the prevention of pneumococcal infections

Composition

Active ingredients:

pneumococcal conjugates (polysaccharide + CRM197):

polysaccharide serotype 4 2 μg;

polysaccharide serotype 6B 4 μg;

polysaccharide serotype 9V2 μg;

serotype polysaccharide 142 mcg;

oligosaccharide serotype 18C 2 μg;

polysaccharide serotype 19F 2 μg;

polysaccharide serotype 23F 2 μg;

carrier protein CRM 197 » 20 µg;

Excipients:

aluminum phosphate;

sodium chloride;

water for injections;

Contraindications

acute infectious and non-infectious diseases, exacerbation of chronic diseases (in these cases, vaccination is carried out after recovery or in remission);
hypersensitivity due to previous administration of Prevenar;
hypersensitivity to excipients and/or diphtheria toxoid.

Side Effects

Local reactions: very often – redness, hardness/swelling, pain/soreness); often – swelling/hardening of the injection site and redness of more than 2.4 cm, pain at the injection site, leading to a short-term limitation of the range of motion of the limb; rarely – allergic reactions at the injection site (dermatitis, itching, urticaria).

General reactions: very often – hyperthermia 38°C and above (per rectum measurement), irritability, drowsiness, restless sleep, tearfulness; often – hyperthermia > 39°C (per rectum measurement); rarely – episodes of arterial hypotension, hyporesponsiveness.

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

From the side of the central nervous system: rarely – convulsions, incl. febrile seizures.

From the digestive system: very often – vomiting, diarrhea, loss of appetite.

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

Other: very rarely – regional lymphadenopathy.

Interaction

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

Vaccines must always be administered to different areas of the body.

Storage conditions

At 2–8 °C (do not freeze)

Shelf life

3 years

Manufacturer

NPO Petrovax Pharm, Russia