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Pharmacological group

Nosological classification (ICD-10)

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Description of the dosage form

White homogeneous suspension.

Characteristic

Prevenar ® 13 vaccine is a 13 pneumococcal serotype capsular polysaccharide: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, individually conjugated to the diphtheria CRM197 protein and adsorbed on aluminum phosphate.

pharmachologic effect

Pharmacological (immunobiological) properties

The introduction of the vaccine Prevenar ® 13 causes the production of antibodies to Streptococcus pneumoniae capsular polysaccharides, thereby providing specific protection against infections caused by vaccines 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F serotypes of pneumococcus.

According to the WHO recommendations, for the new conjugated pneumococcal vaccines, the equivalence of the immune response of the vaccine Prevenar ® 13 was determined according to three criteria: the percentage of patients who reached the concentration of specific IgG antibodies ≥0.35 µg / ml; mean geometric concentrations (SGK) Ig and opsonophagocytic activity (OFA) of bactericidal antibodies (OFA titer ≥1: 8 and average geometric titers (SGT). For adults, the protective level of anti-pneumococcal antibodies is not determined and serotype-specific OFA (SGT) is used.

Prevenar ® 13 vaccine includes up to 90% of serotypes that cause invasive pneumococcal infections (IPI), in

Immune response when using three or two doses in a series of primary vaccinations. After the introduction of three doses of vaccine Prevenar ® 13 in the primary vaccination of children under the age of 6 months marked a significant increase in the level of antibodies to all vaccine serotypes. After the introduction of two doses during primary vaccination, Prevenar ® 13 in the framework of mass immunization of children of the same age group also showed a significant increase in antibody titers to all vaccine components; for serotypes 6B and 23F, the IgG level was ≥0.35 µg / ml in a smaller percentage of children. At the same time, a marked booster response to revaccination was noted for all serotypes. Formation of immune memory is indicated for both of the above vaccination regimens. The secondary immune response to a revaccinating dose in children of the second year of life when using three or two doses in the primary vaccination series is comparable for all 13 serotypes.

When vaccinating premature babies (born with gestational age ® 13, demonstrated an immune response to all 13 serotypes, equivalent to that of children 12-15 months vaccinated with four doses of vaccine Prevenar ® 13.

A single injection of the vaccine Prevenar ® 13 to children aged 5-17 years can provide the necessary immune response to all the serotypes of the pathogen that make up the vaccine.

The effectiveness of the vaccine Prevenar ® 13

FIP. After the introduction of the vaccine Prevenar ® in the 2 + 1 scheme (two doses in the first year of life and revaccination once in the second year of life) after four years with 94% vaccination coverage, 98% (95% CI: 95; 99) showed a decrease in the incidence of IPI caused by vaccine-specific serotypes. After switching to the Prevenar ® 13 vaccine, a further decrease in the incidence of IPI caused by vaccine-specific additional serotypes was observed, from 76% in children under 2 years of age to 91% in children 5-14 years of age. Serotype-specific efficacy in relation to IPI for additional serotypes of Prevenar ® 13 vaccine in children aged ≤ 5 years ranged from 68 to 100% (serotypes 3 and 6A respectively) and amounted to 91% for serotypes 1, 7F and 19A), there were no cases of IPI caused by serotype 5. After inclusion of the vaccine Prevenar ® 13 into national immunization programs, the frequency of registration of IPD caused by serotype 3 decreased by 68% (95% CI: 6–89%) in children under 5 years of age. The case-control study performed in this age group showed a decrease in the incidence of serotype 3 IPI by 79.5% (95% CI: 30.3–94.8).

Otitis media (CO). After the introduction of vaccination of drugs Prevenar ® with the subsequent transition to the vaccine Prevenar ® 13 according to the 2 + 1 scheme, a 95% reduction in the incidence of CO caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and serotype 6A, as well as 89% reduction in the frequency of CO caused by serotypes 1, 3, 5, 7F and 19A.

Pneumonia. When switching from Prevenar ® to Prevenar ® 13, there was a 16% decrease in the incidence of all cases of community-acquired pneumonia (PFS) in children from 1 month to 15 years. Cases of pleural effusion have decreased by 53% (p ® 13 has a 74% decrease in the frequency of PFS caused by 6 additional serotypes of Prevenar ® 13 vaccine. In children younger than 5 years after the introduction of Prevenar ® 13 vaccination, according to the 2 + 1 scheme, 68% (95% CI: 73; 61) decrease in the number of outpatient visits and 32% (95% CI: 39; 22) decrease in the number of hospitalizations for alveolar PFS of any etiology.

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Carrier and population effect. The effectiveness of Prevenar ® 13 vaccine in reducing nasopharyngeal carriage in vaccine-specific serotypes, both common with Prevenar ® vaccine (4, 6В, 9V, 14, 18С, 19F, 23F), and 6 additional (1, 3, 5, 6А , 7A, 19A) and related serotype 6C.

The population effect (serotype-specific reduction in the incidence of unvaccinated individuals) was noted in countries where Prevenar ® 13 has been used as part of mass immunization for more than 3 years with high vaccination coverage and compliance with the immunization schedule. In those who were not vaccinated with Prevenar ® 13, people 65 years and older showed a 25% decrease in FDI, while FDI caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F decreased by 89% and FDI due to 6 additional serotypes (1, 3, 5, 6A, 7A, 19A). The frequency of infections caused by serotype 3 decreased by 44%, by serotype 6A by 95%, by serotype 19A by 65%.

Immunogenicity of Prevenar ® 13 vaccine in adults

Clinical studies of the Prevenar ® 13 vaccine provide data on immunogenicity in adults aged 18 years and older, including those aged 65 and older, and those who have previously been vaccinated with one or more doses of a 23-valent polysaccharide pneumococcal vaccine (PPV23) 5 years before inclusion in the study. In each study, healthy adults and immunocompetent patients with chronic diseases were in the compensation stage, including comorbidities, which form an increased susceptibility to pneumococcal infection (chronic cardiovascular diseases, chronic lung diseases, including asthma; kidney diseases and diabetes mellitus, chronic liver diseases, including alcohol), and adults with social risk factors – smoking and alcohol abuse.

The immunogenicity and safety of Prevenar ® 13 vaccine has been demonstrated for adults aged 18 years and older, including patients previously vaccinated with PPV23. Immunological equivalence was established for 12 common serotypes with PPV23. In addition, for 8 common serotypes with PPV23 and serotype 6A, unique for Prevenar ® 13 vaccine, a higher statistically significant immune response to Prevenar ® 13 vaccine was demonstrated. OFT EGT to all 13 serotypes of Prevenar ® 13 vaccine were not lower than those in adults at the age of 60–64 years. Moreover, persons aged 50–59 years gave a statistically higher immune response to 9 of 13 serotypes compared with people aged 60–64 years.

Clinical efficacy of the Prevenar ® 13 vaccine was demonstrated in a randomized, double-blind, placebo-controlled study CAPITA (more than 84,000 patients) for community-acquired pneumococcal pneumonia (WFP) in adults 65 years and older: 45% for the first episode of WFP caused by serotypes Prevenar ® 13 overlaid vaccines (invasive and non-invasive); 75% – against invasive infections caused by serotypes overlapped by Prevenar ® 13 vaccine.

The immune response in adults previously vaccinated with PPV23

In adults aged 70 and older, once vaccinated PPV23 >5 years ago, the introduction of the Prevenar ® 13 vaccine demonstrated immunological equivalence for 12 common serotypes compared with the response to PPV23, while for 10 common serotypes and the 6A serotype the immune response to the Prevenar ® 13 vaccine was significantly higher than the response to PPV23. Prevenar ® 13 gives a more pronounced immune response compared with revaccination of PPV23.

Immune response in specific patient groups

Patients with the diseases described below are at increased risk of pneumococcal infection.

Sickle cell anemia. In an open non-comparative study involving 158 children and adolescents aged >6 and ® 13 with a double immunization with an interval of 6 months resulted in a statistically significantly high immune response (SGK IgG to each serotype, determined by enzyme immunoassay (ELISA), and OFA SGT to each serotype). After the second dose was administered, the immune response was comparable to that after the first dose of the drug.

HIV infection. HIV-infected children and adults with CD4 >200 cells / µl (average 717 cells / µl), viral load ® 13. The IgG SGK and EFA values ​​were significantly higher after the first vaccination with Prevenar ® 13 vaccine compared with the pre-vaccination level. The second and third doses (after 6 and 12 months) developed a higher immune response than after a single vaccination with Prevenar ® 13 vaccine.

Hematopoietic stem cell transplantation. Children and adults who underwent allogeneic hematopoietic stem cell transplantation (HSCT), aged >Two years with complete hematological remission of the underlying disease or satisfactory partial remission in the case of lymphoma and myeloma received three doses of the vaccine Prevenar ® 13 with an interval of at least 1 month. The first dose of the drug was administered 3–6 months after HSCT. The fourth (booster) dose of the vaccine Prevenar ® 13 was administered 6 months after the third dose. In accordance with the general recommendations, a single dose of PPV23 was administered 1 month after the fourth dose of Prevenar ® 13 vaccine. The titers of functionally active antibodies (OFA of CGT) were not determined in this study. The introduction of the vaccine Prevenar ® 13 caused an increase in CHK serotype-specific antibodies after each dose. The immune response to the booster dose of the vaccine Prevenar ® 13 was significantly higher for all serotypes compared to the response to the primary immunization series.

Indications of the drug Prevenar ® 13 (vaccine pneumococcal polysaccharide conjugated adsorbed, thirteenth)

Prevention of pneumococcal infections, including invasive (in

– as part of the national immunization schedule;

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– in individuals at high risk of developing pneumococcal infection.

Vaccination is carried out within the framework of the national calendar of prophylactic vaccinations in accordance with approved terms, as well as individuals at risk for the development of pneumococcal infection: with immunodeficiency states, in

Contraindications

hypersensitivity reactions to the previous administration of drugs Prevenar ® 13 or Prevenar ® (in

hypersensitivity to diphtheria toxoid and / or excipients;

acute infectious or non-infectious diseases, exacerbation of chronic diseases (vaccination is carried out after recovery or during remission).

Use during pregnancy and lactation

The safety of the vaccine during pregnancy and breastfeeding has not been established. Data on the use of the vaccine Prevenar ® 13 during pregnancy are not available.

There are no data on the release of vaccine antigens or post-vaccination antibodies in breast milk during lactation.

Side effects

The safety of the vaccine Prevenar ® 13 was studied in healthy children (4429 children / 14267 doses of vaccine) from 6 weeks to 11–16 months and 100 children born prematurely (at a time ® 13 was used concurrently with other vaccines recommended for this age. Prevenar ® 13 vaccine safety has been evaluated in 354 children aged 7 months – 5 years old, not previously vaccinated with any of the pneumococcal conjugate vaccines. The most frequent undesirable reactions were reactions at the injection site, fever, irritability, loss of appetite and more sleep patterns. Older children with primary vaccination with Prevenar ® 13 vaccine had a higher frequency of local reactions than children of the first year of life. With Vaccination with Prevenar ® vaccine 13 premature babies (born with a gestation period ® 13

The adverse reactions listed below are classified according to the frequency of their manifestation in all age groups as follows: very often (≥1 / 10); often (≥1 / 100, but ®, however, it is also possible for Prevenar ® 13 vaccine.

** Noted in post-marketing observations of the Prevenar ® vaccine; they can be considered as quite possible for Prevenar ® 13 vaccine.

Adverse events observed in other age groups can also manifest themselves in children and adolescents 5-17 years old. However, in clinical studies they were not noted due to the small number of participants. There were no significant differences in the incidence of side effects in adults previously vaccinated and unvaccinated PPV23.

Interaction

Data on the interchangeability of the vaccine Prevenar ® 13 and other pneumococcal conjugate vaccines are not available. With simultaneous immunization with Prevenar ® 13 vaccines and other vaccines, injections are given in different parts of the body.

Children 2 months – 5 years. Prevenar ® 13 is combined with any other vaccines included in the immunization schedule for infants, with the exception of BCG. The simultaneous introduction of the vaccine Prevenar ® 13 with any of the following antigens that are part of both monovalent and combined vaccines – diphtheria, tetanus, cell-free or whole-cell pertussis, Haemophilus influenzae (type b), poliomyelitis, hepatitis A, coronary heart disease, viral hepatitis B, type III, hepatitis B, hepatitis B, hepatitis B, hepatitis B, hepatitis B, hepatitis B virus , rubella, varicella and rotavirus infection – does not affect the immunogenicity of these vaccines. Due to the higher risk of developing febrile reactions in children with convulsive disorders,

According to a post-marketing study of the prophylactic use of antipyretics on the immune response when the vaccine Prevenar ® 13 is administered, it is assumed that the prophylactic administration of acetaminophen (paracetamol) can reduce the immune response to the series of primary vaccination with the Prevenar ® vaccine 13. The immune response to vaccination booster Prevenar ® 13 in 12 month with prophylactic use of paracetamol does not change. The clinical significance of this data is unknown.

Children and teenagers 6–17 years old. Data on the use of the drug Prevenar ® 13 simultaneously with the human papillomavirus infection vaccine, conjugated meningococcal vaccine, tetanus vaccine, diphtheria and whooping cough, tick-borne encephalitis are not available.

Persons 18–49 years old. Data on the simultaneous use of the drug Prevenar ® 13 with other vaccines are not available.

Persons 50 years and older. Vaccine Prevenar ® 13 can be used in conjunction with trivalent inactivated seasonal influenza vaccine (DVT). With the combined use of Prevenar ® 13 vaccine and DVT, the immune responses to the DVT vaccine coincided with the responses obtained using the DVT vaccine alone, the immune responses to the Prevenar ® 13 vaccine were lower than when using the Prevenar ® vaccine 13 alone. The clinical significance of this fact is unknown.

The frequency of local reactions did not increase with the simultaneous administration of Prevenar ® 13 vaccine with an inactivated influenza vaccine, while the frequency of general reactions (headache, chills, rash, loss of appetite, pain in joints and muscles) increased simultaneously. Simultaneous use with other vaccines has not been studied.

Dosage and administration

The vaccine is administered in a single dose of 0.5 ml. Children of the first years of life are vaccinated to the upper outer surface of the middle third of the thigh, to persons older than 2 years old – to the deltoid muscle of the shoulder.

Before using the syringe with Prevenar ® 13 vaccine, shake well to obtain a homogeneous suspension. Do not use if foreign particles are detected when inspecting the contents of the syringe or the contents look different than in the “Description of the dosage form” section.

Do not administer the vaccine Prevenar ® 13 intravascular and intramuscular in the buttock.

If vaccination with Prevenar ® 13 vaccine is started, it is recommended to complete it also with Prevenar ® 13 vaccine. With a forced increase in the interval between injections of any of the above vaccination courses, the introduction of additional doses of Prevenar ® 13 vaccine is not required.

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