To strengthen immunity, resist infections, vaccination of the population helps, but many refuse it because of side effects on the body. Therefore, you need to be aware of the reaction to the Prevenar vaccine against pneumococcus, which has been introduced as a recommendation since 2014. The need for such vaccination arose due to the increased incidence of diseases - pneumonia, otitis media, bronchitis, tonsillitis, sepsis. And antibiotics can not cope with the infection due to the resulting addiction to them.
Vaccination of children and adults is used so that the body can fight back against bacteria that cause serious illness. Doctors inform about what the Prevenar vaccine helps with and how it affects the body.
Inside the vaccination suspension are variants of streptococcus, which includes particles of pneumococcus, a diphtheria protein. The number 13 indicates the number of serotype variants that cause the development of complex infections in the human body.
Once in the human body, the drug prepares it for a meeting with the infection. Cells after vaccination remember information about the stranger. And they will react to the presence of pneumococcus in the body, releasing antibodies to fight the cells of foreign bacteria.
Against pneumococcal infections, especially in children, Prevenar 13 is one hundred percent effective.
Features of the vaccine
Among infectious diseases pneumococcal occurs in 80 percent of cases. It causes pneumonia, and also leads to meningitis, sepsis, otitis media. Among children younger age pneumococcus is spreading by airborne droplets leading some of the babies to death. Susceptibility to infection is detected in:
- babies up to two years old;
- premature babies;
- children with pathologies of the respiratory system, immunodeficiency, diabetes mellitus;
- patients with allergic reactions.
To prevent infection, reduce possible complications use vaccination with Prevenar 13.
The suspension is diluted and administered to children intramuscularly from the age of two months.
The vaccine is not mixed with other drugs. But they are vaccinated together with others, with DPT, injecting into different areas body.
Prevenar 13 is tolerated without complications. But in some children, the Prevenar vaccine causes the body's response to pneumococcus in the form of swelling at the injection site. There is also such a reaction as an increase in temperature to the Prevenar vaccination.
To avoid unexpected reactions of the body, the vaccinated child is under the supervision of a pediatrician. The temperature in a child after vaccination lasts no more than a day. If it does not decrease, then you should immediately consult a doctor. cases anaphylactic shock after vaccination was not registered.
Vaccination analogues Prevenar 13
You can replace the pneumococcal vaccine Prevenar with analogs with a similar effect:
- Pneumo 23 is produced in France. The vaccine contains 23 serological types of pneumococcus. The syringe contains single dose drug. The vaccine is placed in the muscle of the shoulder or thigh. Vaccination is possible along with other vaccinations of the DPT group. A month later, the patient develops immunity against pneumococcal infections. The vaccine is given not only to children, but also to adults up to 64 years of age.
- For the prevention of diseases, the second generation vaccine Synflorix is used. It consists of ten antigens of bacteria of the streptococcal group. In addition to these infections, the vaccine generates an immune response to Haemophilus influenzae. Children are vaccinated from two months to two years.
From vaccinations, the main Prevenar 13 s a wide range actions. All pneumococcal vaccines are actively used because drugs against bacteria cannot cope with the infection due to resistance. pathogenic microorganisms to them. It remains only to hope for a vaccine.
How effective is vaccination
The preventive effect of vaccination against pneumococcus will be effective and the reaction to Prevenar 13 will decrease if a number of rules are followed:
- Before the introduction of the vaccine, the child is carefully examined by a pediatrician, if necessary, appoints to take tests.
- After the procedure, the injection site should not be wetted with water. A day later, the child is bathed.
- Walking is allowed only in good weather. For a while, it is better to avoid crowded places, visiting guests, in order to exclude contact with carriers of pathogenic bacteria.
- The child's nutrition is continued according to the old scheme, without introducing new products. Allergy occurs to unfamiliar foods.
Vaccination Prevenar 13 is given to children and adults. At the age of over two years, the drug is injected into the muscle of the shoulder. Small - in the thigh.
Every child reacts differently to vaccination. Some carry it easily without adverse reactions while others are difficult.
Indications for use
Protecting the baby from pneumococcal infection is the main goal of vaccination with Prevenar 13. If we talk about babies, they give a vaccination injection to those who have a weakened body. This applies to children born prematurely. In order for the child's body to resist streptococci in the first months of life, this can be achieved by vaccination. The administration of the drug to adults is indicated, those who have:
- age over 65;
- diagnosed with diabetes;
- poor liver function due to cirrhosis;
- the body is weakened by immunodeficiency;
- pathology of the lungs, kidneys, heart and blood vessels.
But there are contraindications to vaccination. They should be taken into account when referring a patient for pneumococcal vaccination.
Contraindications to the use of Prevenar 13
There are prohibitions on the use of Prevenar. Do not inject the drug to those who:
- has hypersensitivity to a substance detected during the previous vaccination;
- infected with an acute infection;
- has complications after an illness.
Allergy as a reaction to the Prevenar vaccine may become an obstacle to vaccination. Caution should be exercised when vaccinating women during pregnancy and lactation. It is better to refuse vaccination for this time in order to protect yourself and the fetus from possible consequences. In the development of complications, an important role is played by intolerance not only to the main components of the drug, but also to additional ones - aluminum phosphate, sodium chloride.
Route of administration and doses for children and adolescents
From the options for using a prophylactic suspension, choose the one that suits a particular person. The scheme depends on the age of the patient. Doctors believe that children over three years old and adults under 60 years of age can not be vaccinated with Prevenar. Their body has developed immunity to those diseases that patients have been ill with.
The vaccination scheme for children from 2 to 6 months of age is as follows: the vaccine is given three times with an interval of four weeks.
For babies at the age of seven months, immunization is carried out twice.
The scheme of vaccination of children from one to two years is similar. Vaccinated once, they receive Prevenar again after a month or two.
A child older than 2 years of age is not given a second vaccination. Revaccination is carried out once a year, regardless of the age of the patient.
Since the drug is available in the form of a suspension in a disposable syringe, it is not necessary to dose it. The liquid has transparency, without impurities and turbidity. Shake the syringe before injection.
The introduction takes place intramuscularly, the drug Prevenar is placed:
- babies up to two years of age upper part thighs on the outside;
- children from two years old, adolescents and adults - in the shoulder area, deltoid muscle;
- cannot be administered intravenously;
- it is not recommended to inject into the muscle of the buttocks.
The needle enters the muscle completely so that the solution has its effect. preventive action on the patient's body.
Side effects after vaccination
Usually, the Prevenar vaccine does not give any reaction. Among possible reactions on vaccination note the appearance of:
- elevated body temperature;
- in a third of patients - pain in the injection area or tissue swelling;
- irritability, lethargy, drowsiness;
- nausea and vomiting, loss of appetite.
If the temperature rises after the Prevenar vaccination, then this is considered normal. It is worth worrying when the temperature remains high for more than 2-3 days. Among the complications after vaccination may be convulsions, respiratory arrest. Such consequences appear if contraindications for the administration of the drug are not taken into account.
A month later, the vaccine will begin to act, and the diseases caused by pneumococcus will bypass the baby.
What do doctors not always talk about?
Before vaccination, patients who are prone to allergic reactions. Warn the doctor about this before the procedure. If the condition before immunization requires an examination or tests, then these procedures are carried out without fail.
Revaccination is carried out for adults after 12 months, children under two years old - from four to eight months.
The peculiarity of the vaccine is that it stimulates the body's defenses a month after vaccination. The drug must not be stored in freezer. The vaccine in the syringe is taken fresh.
Thanks to the Prevenar 13 vaccine, a child and an adult will protect their body from pneumonia, otitis, infection complications - meningitis, sepsis. For most people, vaccination is a lifesaver.
PREVENAR
® 13
(vaccine pneumococcal polysaccharide conjugated adsorbed, thirteen-valent)
INTERNATIONAL NON-PROPRIETARY OR GROUPED NAME:
vaccine for
prevention pneumococcal infectionsPHARMACEUTICAL FORM: suspension for intramuscular injection
Price: 3900 r.
Prevenar ® 13 vaccine is a capsular polysaccharide of 13 pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, individually conjugated to the diphtheria protein CRM 197 and adsorbed on aluminum phosphate .
COMPOUND
Composition per dose (0.5 ml):
Active substances :
Pneumococcal conjugates (polysaccharide — CRM 197):
Excipients : aluminum phosphate - 0.5 mg (in terms of aluminum 0.125 mg), sodium chloride - 4.25 mg, succinic acid- 0.295 mg, polysorbate 80 - 0.1 mg, water for injection - up to 0.5 ml.
DESCRIPTION
Homogeneous suspension of white color.
PHARMACOTHERAPEUTIC GROUP: MIBP vaccine.
ATX code: J07AL02
IMMUNOLOGICAL PROPERTIES
The introduction of the vaccine Prevenar ® 13 causes the production of antibodies to capsular polysaccharides Streptococcus pneumoniae, thereby providing specific protection against infections caused by pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F included in the vaccine.
According to the WHO recommendations for new pneumococcal conjugate vaccines, the equivalence of the immune response of Prevenar ® 13 was determined according to three criteria: the percentage of patients who reached the concentration of specific IgG antibodies³ 0.35 µg/ml; geometric mean concentrations (SGK) of immunoglobulins and opsonophagocytic activity (OFA) of bactericidal antibodies (OFA titer ³ 1:8 and geometric mean titers (SGT)). For adults, a protective level of anti-pneumococcal antibodies has not been determined and serotype-specific OFA (SGT) is used.
The vaccine Prevenar ® 13 includes up to 90% of serotypes that cause invasive pneumococcal infections (IPI), including those resistant to antibiotic treatment.
Immune response when using three or two doses in a series of primary vaccinations
After the introduction three doses Prevenar ® 13 during the primary vaccination of children under the age of 6 months, a significant increase in the level of antibodies to all vaccine serotypes was noted.
After the introduction two doses during primary vaccination with Prevenar ® 13 as part of the mass immunization of children of the same age group there is also a significant rise in antibody titers to all components of the vaccine; for serotypes 6B and 23F, the level of IgG ³ 0.35 μg / ml was determined in a smaller percentage of children. At the same time, a pronounced booster response to revaccination was noted for all serotypes. The formation of immune memory is shown for both of the above vaccination schemes. Secondary immune response to a booster dose in children of the second year of life when using three or two doses in the primary vaccination series are comparable for all 13 serotypes.
When vaccinating premature babies (born at gestational age<37 недель), включая глубоко-недоношенных детей (родившихся при сроке гестации <28 недель), начиная с возраста двух месяцев, отмечено, что уровень защитных специфических противопневмококковых антител и их ОФА после законченного курса вакцинации достигали значений выше защитных у 87-100% привитых ко всем тринадцати включенным в вакцину серотипам.
Immunogenicity in children and adolescents aged 5 to 17 years
Children aged 5 to<10 лет, которые до этого получили как минимум одну дозу пневмококковой 7-валентной конъюгированной вакцины, а также ранее не вакцинированные дети и подростки в возрасте от 10 до 17 лет, получив по одной дозе вакцины Превенар ® 13, продемонстрировали иммунный ответ на все 13 серотипов, эквивалентный таковому у детей 12-15 месяцев, вакцинированных четырьмя дозами препарата Превенар ® 13.
A single administration of Prevenar ® 13 to children aged 5-17 years can provide the necessary immune response to all serotypes of the pathogen that are part of the vaccine.
Efficacy of Prevenar ® 13
Invasive pneumococcal infection (IPI)
After the introduction of Prevenar ® in the 2 + 1 regimen (two doses in the first year of life and a single revaccination in the second year of life), after four years, with 94% vaccination coverage, there was a 98% (95% CI: 95; 99) reduction in the incidence of IPD caused by vaccines -specific serotypes. After switching to Prevenar ® 13, there was a further decrease in the incidence of IPD caused by vaccine-specific additional serotypes, from 76% in children under the age of 2 years to 91% in children aged 5-14 years.
Serotype-specific efficacy against IPI for additional Prevenar 13 serotypes in children aged ≤ 5 years ranged from 68% to 100% (serotype 3 and 6A, respectively) and was 91% for serotypes 1, 7F and 19A), with no cases of IPD caused by serotype 5 were observed. After the inclusion of Prevenar ® 13 in national immunization programs, the incidence of IPD caused by serotype 3 decreased by 68% (95% CI 6-89%) in children under 5 years of age. A case-control study performed in this age group showed a reduction in the incidence of IPD caused by serotype 3 by 79.5% (95% CI 30.3-94.8). Otitis media (SO)
After the introduction of Prevenar ® vaccination followed by the transition to Prevenar ® 13 according to the 2 + 1 scheme, a 95% decrease in the incidence of OS caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and serotype 6A, as well as by 89% reduction in the frequency of CO caused by serotypes 1, 3, 5, 7F and 19A.
Pneumonia
When switching from Prevenar ® to Prevenar ® 13, a 16% reduction in the incidence of all cases of community-acquired pneumonia (CAP) in children aged 1 month to 15 years was noted. PFS cases with pleural effusion decreased by 53% (p< 0,001), пневмококковые ВБП снизились на 63 % (р < 0,001). Во второй год после внедрения Превенар ® 13 отмечено 74 % снижение частоты ВБП, вызванных 6 дополнительными серотипами Превенар ® 13. У детей в возрасте младше 5 лет после внедрения вакцинации Превенар ® 13 по схеме 2+1 отмечено 68 % (95 % ДИ: 73; 61) снижение числа амбулаторных визитов и 32 % (95 % ДИ: 39; 22) уменьшение числа госпитализаций по поводу альвеолярной ВБП любой этиологии.
Carriage and population effect
The effectiveness of Prevenar ® 13 in reducing carriage in the nasopharynx of vaccine-specific serotypes, both common with Prevenar ® (4, 6B, 9V, 14, 18C, 19F, 23F), and 6 additional (1, 3, 5, 6A , 7A, 19A) and related serotype 6C.
A population effect (serotype-specific reduction in the incidence of unvaccinated individuals) has been noted in countries where Prevenar ® 13 has been used as part of mass immunization for more than 3 years with high vaccination coverage and adherence to the immunization schedule. Unvaccinated Prevenar® 13 individuals aged 65 years and older demonstrated a 25% reduction in IDI, while IDI caused by serotypes 4, 6B, 9V, 14, 18C, 19F, 23F decreased by 89% and IDI caused by 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 Prevenar 13 provide data on immunogenicity in adults aged 18 years and older, including those aged 65 years and older and those previously vaccinated with one or more doses of pneumococcal polysaccharide 23-valent vaccine (PPV23) 5 years prior to inclusion into research. Each study included healthy adults and immunocompetent patients with chronic diseases in the stage of compensation, including comorbidities that form an increased susceptibility to pneumococcal infection (chronic cardiovascular disease, chronic lung disease, including asthma; kidney disease and diabetes mellitus, chronic liver disease, including alcohol injury), and adults with social risk factors such as smoking and alcohol abuse. The immunogenicity and safety of Prevenar 13 has been demonstrated in adults 18 years of age and older, including patients previously vaccinated with PPV23. Immunological equivalence was established for 12 serotypes common with PPV23. In addition, 8 serotypes in common with PPV23 and serotype 6A, which is unique to Prevenar ® 13 vaccine, demonstrated a statistically significantly higher immune response to Prevenar ® 13. 13 serotypes of Prevenar ® 13 were not lower than those in adults aged 60-64 years. Moreover, individuals aged 50-59 years had a statistically higher immune response to 9 of 13 serotypes compared to those aged 60-64 years.
Clinical efficacy of Prevenar® 13 was demonstrated in the randomized, double-blind, placebo-controlled CAPITA study (more than 84,000 patients) against community-acquired pneumococcal pneumonia (CAP) in adults aged 65 years and older: 45% against the first episode of CAP caused by serotypes overlapping Prevenar ® 13 (invasive and non-invasive); 75% for invasive infections caused by serotypes covered by Prevenar 13.
Immune response in adults previously vaccinated with PPV23
In adults aged 70 years and older who were vaccinated once with PPV23 ≥ 5 years ago, Prevenar 13 administration demonstrated immunological equivalence for 12 common serotypes compared to the response to PPV23, with 10 common serotypes and serotype 6A immune response to Prevenar 13 was statistically significantly higher compared to the response to PPV23. Prevenar ® 13 gives a more pronounced immune response compared to revaccination with PPV23.
Immune response in special groups of patients
Patients with the conditions described below are at increased risk of pneumococcal infection.
sickle cell anemia
In an open, non-comparative study of 158 children and adolescents aged ≥ 6 and< 18 лет с серповидно-клеточной анемией, ранее вакцинированных одной или более дозами ППВ23 как минимум за 6 месяцев до включения в исследование показало, что введение первой дозы Превенар ® 13 при двукратной иммунизации с интервалом 6 месяцев приводило к статистически значимо высокому иммунному ответу (СГК IgG к каждому серотипу, определяемые методом иммуноферментного анализа (ИФА ), и ОФА СГТ к каждому серотипу). После ведения второй дозы иммунный ответ был сопоставим с таковыми после первой дозы препарата.
HIV infection
HIV-infected children and adults with a CD4 count ≥ 200 cells/μL (mean 717.0 cells/μL), viral load< 50 000 копий/мл (в среднем 2090,0 копий/мл), с отсутствием активных СПИД-ассоциированных заболеваний и ранее не получавшие вакцинации пневмококковой вакциной, получали 3 дозы Превенар ® 13. Показатели IgG СГК и ОФА были достоверно выше после первой вакцинации Превенар ® 13 по сравнению с довакцинальным уровнем. На вторую и третью дозы (через 6 и 12 месяцев) развивался более высокий иммунный ответ, чем после однократной вакцинации Превенар ® 13.
Hematopoietic stem cell transplantation
Children and adults who underwent allogeneic hematopoietic stem cell transplantation (HSCT), aged ≥ 2 years with complete hematological remission of the underlying disease or with satisfactory partial remission in the case of lymphoma and myeloma, received three doses of Prevenar ® 13 at least 1 month apart between doses. The first dose of the drug was administered 3-6 months after HSCT. The fourth (booster) dose of 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. Titers of functionally active antibodies (OPA GT) were not determined in this study. The introduction of Prevenar ® 13 caused an increase in SGC serotype-specific antibodies after each dose. The immune response to the booster dose of Prevenar ® 13 was significantly higher for all serotypes compared to the response to the primary immunization series.
INDICATIONS FOR USE
- prevention of pneumococcal infections, including invasive (including meningitis, bacteremia, sepsis, severe pneumonia) and non-invasive (community-acquired pneumonia and otitis media) forms of diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F from 2 months of age onwards without age limit:
- within the framework of the national calendar of preventive vaccinations;
- in individuals at increased risk of developing pneumococcal infection.
Vaccination is carried out within the framework of the national calendar of preventive vaccinations according to the approved deadlines, as well as for persons at risk for the development of pneumococcal infection: with immunodeficiency states, incl. HIV infection, oncological diseases receiving immunosuppressive therapy; with anatomical/functional asplenia; with a cochlear implant or planned for this operation; patients with leakage of cerebrospinal fluid; with chronic diseases of the lungs, cardiovascular system, liver, kidneys and diabetes mellitus; patients with bronchial asthma; premature babies; persons who are in organized groups (orphanages, boarding schools, army groups); convalescents of acute otitis media, meningitis, pneumonia; long-term and frequently ill children; patients infected with Mycobacterium tuberculosis; all persons over 50 years of age; tobacco smokers.
CONTRAINDICATIONS
- Hypersensitivity to previous administration of Prevenar ® 13 or Prevenar ® (including anaphylactic shock, severe generalized allergic reactions);
- hypersensitivity to diphtheria toxoid and / or excipients;
- acute infectious or non-infectious diseases, exacerbations of chronic diseases. Vaccination is carried out after recovery or during remission.
USE IN PREGNANCY AND DURING BREASTFEEDING
The safety of the vaccine during pregnancy and breastfeeding has not been established. There are no data on the use of Prevenar ® 13 during pregnancy. There are no data on the isolation of vaccine antigens or post-vaccination antibodies in breast milk during lactation.
METHOD OF APPLICATION AND DOSESS
Method of administration
The vaccine is administered in a single dose of 0.5 ml intramuscularly. For children of the first years of life, vaccinations are carried out in the upper outer surface of the middle third of the thigh, for persons older than 2 years - in the deltoid muscle of the shoulder.
Before use, the syringe with the vaccine Prevenar ® 13 should be shaken well until a homogeneous suspension is obtained. Do not use if foreign particles are detected upon inspection of the contents of the syringe, or the contents look different than in the "Description" section of this instruction.
Do not inject Prevenar ® 13 intravascular and intramuscular in the gluteal region!
If vaccination with Prevenar ® 13 is started, it is recommended to complete it also with Prevenar ® 13 vaccine. If the interval between injections of any of the above vaccination courses is forced to increase, additional doses of Prevenar ® 13 are not required.
Vaccination scheme
|
Age of start of vaccination |
Vaccination scheme |
Intervals and dosage |
|
2 -6 months |
Individual immunization: 3 doses with an interval of at least 4 weeks between injections. The first dose can be administered from 2 months. Revaccination once every 11-15 months. Mass immunization of children: 2 doses with an interval of at least 8 weeks between injections. Revaccination once every 11-15 months. |
|
|
7-11 months |
2 doses with an interval of at least 4 weeks between injections. Revaccination once in the second year of life |
|
|
12-23 months |
2 doses with an interval of at least 8 weeks between injections |
|
|
2 years and older |
once |
Children previously vaccinated with Prevenar ®
Pneumococcal vaccination initiated with Prevenar ® 7-valent vaccine may be continued with Prevenar ® 13 at any stage of the immunization schedule.
Persons aged 18 and over
Prevenar ® 13 is administered once. The need for revaccination with Prevenar ® 13 has not been established. The decision on the interval between the administration of Prevenar ® 13 and PPV23 vaccines should be made in accordance with official guidelines.
Special patient groups
In patients after hematopoietic stem cell transplantation, an immunization series consisting of 4 doses of Prevenar ® 13 0.5 ml is recommended. The first series of immunization consists of three doses of the drug: the first dose is administered from the third to the sixth month after transplantation. The interval between injections should be 1 month. A booster dose is recommended 6 months after the third dose.
Premature babies are recommended to be vaccinated four times. The first series of immunization consists of 3 doses. The first dose should be administered at 2 months of age, regardless of the child's body weight, with an interval of 1 month between doses. The introduction of the fourth (booster) dose is recommended at the age of 12-15 months.
Elderly patients
The immunogenicity and safety of Prevenar ® 13 have been confirmed in elderly patients.
SIDE EFFECT
The safety of Prevenar ® 13 was studied in healthy children (4429 children/14267 vaccine doses) aged 6 weeks to 11-16 months and 100 children born prematurely (at term).< 37 недель гестации). Во всех исследованиях Превенар ® 13 применялся одновременно с другими вакцинами, рекомендованными для данного возраста.
In addition, the safety of Prevenar ® 13 was evaluated in 354 children aged 7 months to 5 years who had not previously been vaccinated with any of the pneumococcal conjugate vaccines. The most commonly reported adverse reactions were injection site reactions, fever, irritability, decreased appetite, and sleep disturbance. In older children, during the primary vaccination with Prevenar ® 13, a higher frequency of local reactions was observed than in children of the first year of life.
When 13 preterm infants (born at gestational age ≤ 37 weeks) were vaccinated with Prevenar ®, including very preterm infants born at gestational age less than 28 weeks and children with extremely low body weight (≤ 500 g), the nature, frequency and severity of post-vaccination reactions did not differ from those in term infants.
Those aged 18 years and older had fewer side effects, regardless of previous vaccinations. However, the frequency of reactions was the same as in younger vaccinated patients.
In general, the frequency of side effects was the same in patients aged 18-49 years and in patients over 50 years of age, with the exception of vomiting. This side effect in patients aged 18-49 years was more common than in patients over the age of 50 years.
In adult patients with HIV infection, the frequency of adverse reactions was the same as in patients aged 50 years and older, with the exception of fever and vomiting, which were observed very often and nausea, which was observed frequently.
In patients after hematopoietic stem cell transplantation, the incidence of adverse reactions was the same as in healthy adults, with the exception of fever and vomiting, which were very common in patients after transplantation. Children and adolescents with sickle cell anemia, HIV infection, or after hematopoietic stem cell transplantation had the same frequency of adverse reactions as in healthy patients aged 2-17 years, with the exception of headache, vomiting, diarrhea, fever, fatigue, arthralgia and myalgias, which in such patients were found to be "very frequent".
The adverse reactions listed below are classified according to their frequency in all age groups as follows: very common (≥ 1/10), frequent (≥ 1/100, but< 1/10), нечастые (≥ 1/1000, но < 1/100), редкие (≥ 1/10000, но < 1/1000) и очень редкие (≤ 1/10000).
Adverse reactions identified in clinical studies Prevenar ® 13
Very common: hyperthermia; irritability; redness of the skin, pain, induration or swelling of 2.5-7.0 cm in size at the injection site (after revaccination and / or in children aged 2-5 years); vomiting (in patients aged 18-49 years), drowsiness, sleep disturbance, loss of appetite, headache, generalized new or exacerbation of existing joint and muscle pain, chills, fatigue.
Frequent: hyperthermia above 39 ° C; pain at the injection site, leading to a short-term limitation of the range of motion of the limb; hyperemia, thickening or swelling of 2.5-7.0 cm at the injection site (after a series of primary vaccinations in children under 6 months of age), vomiting, diarrhea, rash.
Infrequent: skin redness, induration or swelling larger than 7.0 cm at the injection site; tearfulness, convulsions (including febrile convulsions), hypersensitivity reactions at the injection site (urticaria, dermatitis, itching)**, nausea.
Rare: cases of hypotonic collapse*, flushing of the face**, hypersensitivity reaction, including shortness of breath, bronchospasm, Quincke's edema of various localization, including swelling of the face**, anaphylactic / anaphylactoid reaction, including shock**, lymphadenopathy at the injection site.
Very rare: regional lymphadenopathy**, erythema multiforme**.
* - observed only in clinical studies of the vaccine Prevenar ® , but possible for Prevenar ® 13.
** - noted during post-marketing observations of the vaccine Prevenar ® ; they can be considered as quite possible for Prevenar ® 13.
Adverse events observed in other age groups can also occur in children and adolescents aged 5-17 years. However, they were not noted in clinical studies due to the small number of participants.
There were no significant differences in the incidence of side effects between previously vaccinated and unvaccinated adults with PPV23.
OVERDOSE
An overdose of Prevenar ® 13 is unlikely, as the vaccine is released in a syringe containing only one dose.
INTERACTIONS WITH OTHER DRUGS AND OTHER INTERACTIONS
Data on the interchangeability of Prevenar ® 13 with other pneumococcal conjugate vaccines are not available. With simultaneous immunization with Prevenar ® 13 and other vaccines, injections are made in different parts of the body.
Children aged 2 months - 5 years
Prevenar ® 13 is combined with any other vaccines included in the immunization calendar for children in the first years of life, with the exception of BCG. Simultaneous administration of Prevenar ® 13 vaccine with any of the following antigens, which are part of both monovalent and combined vaccines: diphtheria, tetanus, acellular or whole cell pertussis, haemophilus influenzae type b, polio, hepatitis A, hepatitis B, measles, mumps, rubella, chickenpox 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, including those with a history of febrile convulsions, and also receiving Prevenar ® 13 simultaneously with whole cell pertussis vaccines, symptomatic antipyretic administration is recommended. With the combined use of Prevenar ® 13 and Infanrix-hexa, the frequency of febrile reactions coincided with that for the combined use of Prevenar ® (PCV7) and Infanrix-hexa. An increase in the frequency of reporting seizures (with and without fever) and hypotonic-hyporesponsive episodes (HGE) was observed with the combined use of Prevenar ® 13 and Infanrix-hexa. The use of antipyretic drugs should be started in accordance with local recommendations for the treatment of children with convulsive disorders or children with a history of febrile seizures, and in all children who received Prevenar ® 13 simultaneously with vaccines containing a whole cell pertussis component.
Based on data from a post-marketing study of prophylactic use of antipyretics on the immune response to Prevenar ® 13 vaccine, it is suggested that prophylactic administration of acetaminophen (paracetamol) may reduce the immune response to the Prevenar ® 13 primary vaccination series. prophylactic use of paracetamol does not change. The clinical significance of these data is unknown.
Children and adolescents aged 6 - 17 years
Data on the use of the drug Prevenar ® 13 simultaneously with the vaccine against human papillomavirus infection, meningococcal conjugate vaccine, vaccine against tetanus, diphtheria and whooping cough, tick-borne encephalitis are not available.
Persons aged 18-49 years
Data on the simultaneous use of the drug Prevenar ® 13 with other vaccines are not available.
Persons aged 50 and over
The vaccine Prevenar ® 13 can be used together with the trivalent inactivated seasonal influenza vaccine (DVT). With the combined use of Prevenar ® 13 and DVT vaccines, immune responses to DVT vaccine coincided with those obtained with DVT vaccine alone, immune responses to Prevenar ® 13 vaccine were lower than when using Prevenar ® 13 alone. The clinical significance of this fact is unknown. The frequency of development of local reactions did not increase with the simultaneous administration of Prevenar ® 13 with an inactivated influenza vaccine, while the frequency of general reactions (headache, chills, rash, loss of appetite, pain in the joints and muscles) increased with simultaneous immunization. Co-administration with other vaccines has not been studied.
SPECIAL INSTRUCTIONS AND PRECAUTIONS FOR USE
Given the rare cases of anaphylactic reactions associated with the use of any vaccine, the vaccinated patient should be under medical supervision for at least 30 minutes after immunization. Immunization sites should be provided with anti-shock therapy.
Vaccination of premature (as well as full-term) children should be started from the second month of life (passport age). When deciding whether to vaccinate a premature baby (born at term< 37 недель беременности), особенно имеющего в анамнезе незрелость дыхательной системы, необходимо учесть, что польза иммунизации против пневмококковой инфекции у данной группы пациентов особенно высока и не следует ни отказываться от вакцинации, ни переносить ее сроки. В связи с потенциальным риском апноэ, имеющимся при применении любых вакцин, первая вакцинация Превенар ® 13 недоношенного ребенка возможна под врачебным наблюдением (не менее 48 ч) в стационаре на втором этапе выхаживания.
As with other intramuscular injections, in patients with thrombocytopenia and / or other disorders of the blood coagulation system and / or in the case of treatment with anticoagulants, vaccination with Prevenar ® 13 should be carried out with caution, provided that the patient's condition is stabilized and hemostasis control is achieved. It is possible to administer the vaccine Prevenar ® 13 subcutaneously to this group of patients.
Prevenar ® 13 cannot prevent diseases caused by pneumococci of other serotypes, antigens of which are not included in this vaccine.
Children from high-risk groups under the age of 2 years should receive primary vaccination with Prevenar ® 13 according to age. In patients with impaired immunoreactivity, vaccination may be accompanied by a reduced level of antibody production.
Application of Prevenar ® 13 and PPV23
For the formation of immune memory, immunization against pneumococcal infection is preferably started with Prevenar ® 13 vaccine. The need for revaccination has not been determined. In high-risk individuals, PPV23 administration may be recommended in the future to expand serotype coverage. There are data from clinical trials of PPV23 vaccination 1 year later, as well as 3.5-4 years after Prevenar ® 13 vaccine. With an interval between vaccinations of 3.5-4 years, the immune response to PPV23 was higher without changes in reactogenicity.
For children vaccinated with Prevenar ® 13 who are at high risk (eg, sickle cell anemia, asplenia, HIV infection, chronic disease, or immune dysfunction), PPV23 is administered at least 8 weeks apart. Conversely, patients at high risk for pneumococcal disease (patients with sickle cell disease or HIV infection), including those previously vaccinated with one or more doses of PPV23, may receive at least one dose of Prevenar 13.
The decision on the interval between the administration of PPV23 and Prevenar ® 13 should be made in accordance with official recommendations. In a number of countries (USA) the recommended interval is at least 8 weeks (up to 12 months). If the patient has previously been vaccinated with PPV23, Prevenar ® 13 should be administered no earlier than 1 year later. In the Russian Federation, PCV13 vaccination is recommended for all adults over the age of 50 and patients at risk, with PCV13 vaccine administered first, with a possible subsequent PPV23 revaccination at least 8 weeks apart.
Prevenar ® 13 contains less than 1 mmol sodium (23 mg) per dose, i.e. practically does not contain sodium.
Within the specified expiration date, Prevenar ® 13 is stable for 4 days at temperatures up to 25 °C. At the end of this period, the drug should either be used immediately or returned to the refrigerator. These data are not guidelines for storage and transport conditions, but may form the basis for a decision on the use of the vaccine in the event of temporary temperature fluctuations during storage and transport.
Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms
Prevenar ® 13 has no or negligible effect on the ability to drive and use machinery. However, some of the reactions listed in the "Side effect" section may temporarily affect the ability to drive a vehicle and potentially dangerous mechanisms.
Release form
Suspension for intramuscular injection 0.5 ml/dose.
5 syringes in a plastic package sealed with plastic wrap.
2 plastic packs and 10 sterile needles, together with instructions for use, in a cardboard box.
When packing at NPO Petrovax Pharm LLC:
0.5 ml in a 1 ml syringe made of transparent colorless glass (type I).
1 syringe and 1 sterile needle in a plastic package sealed with plastic wrap. 1 plastic package with instructions for use in a cardboard box.
Storage and transportation conditions
At temperatures from 2 to 8°C. Do not freeze.
Keep out of the reach of children.
Transport at temperatures between 2 °C - 25 °C. Do not freeze.
Transportation at temperatures above 2-8 °C is allowed for no more than five days.
Best before date
Do not use after the expiry date stated on the packaging.
Holiday conditions
Pack with 1 syringe - by prescription
Pack of 10 syringes - for medical institutions
Manufacturing company
Packed:
NPO Petrovax Pharm LLC, Russian Federation
142143, Moscow region, Podolsky district, s. Pokrov, st. Sosnovaya, 1
Consumer claims should be sent to:
- Pfizer LLC
123112 Moscow, Presnenskaya nab., 10, BC Tower on Naberezhnaya (Block C)
Phone: (495) 287-5000 Fax: (495) 287-5300
2) NPO Petrovax Pharm LLC, Russian Federation
142143, Moscow region, Podolsky district, s. Pokrov, st. Sosnovaya, 1
Phone/fax: (495) 926-2107, e-mail: [email protected]
3) Federal Service for Surveillance in Healthcare (Roszdravnadzor):
109074, Moscow, Slavyanskaya sq., 4, building 1
Tel: (495) 698-4538; (499) 578-0230
Pneumococcal infections are one of the most dangerous childhood diseases and are extremely difficult to treat. One of the most effective ways to protect your baby from them is vaccination. The vaccine "Prevenar" is one of the most effective drugs that allows you to create a child's immunity against pneumococcal infections.
The effectiveness of immunization depends on the scheme of its implementation, when the vaccination is given, and behavior after the procedure. Vaccination is a complex process, so parents should know the composition of the drug administered to the baby, contraindications to its use and how to behave after vaccination. All this will help protect the child from possible complications.
What will Prevenar protect against?
The number "13" in the name of the drug "Prevenar 13" means that it allows you to protect babies from 13 serotypes of pneumococcal bacteria. The risk group for the incidence of infections caused by these microorganisms includes children under 2 years of age, whose immune system is not yet fully formed, as well as older people over 60 years of age with weakened immunity due to natural age-related changes.
The concept of "pneumococcal infection" includes the following diseases dangerous to children's health:
- pneumonia;
- otitis media;
- meningitis;
- sinusitis.
Much less often, pneumococci provoke the development of:
- endocarditis;
- septic arthritis;
- primary peritonitis;
- phlegmon.
After the Prevenar vaccination, children develop strong immunity against all of the listed diseases.
However, according to experts, this drug does not give an absolute guarantee that the baby will not get pneumonia or other infections caused by pneumococci. However, with the development of any of these diseases, vaccinated children tolerate them much more easily, and severe complications are excluded.
The composition of the vaccine and the schedule of vaccination
Dear reader!
This article talks about typical ways to solve your questions, but each case is unique! If you want to know how to solve your particular problem - ask your question. It's fast and free!
The manufacturer of this vaccine is the American pharmaceutical corporation Pfizer Inc. The vaccine does not apply to live vaccinating solutions; killed or weakened strains of microorganisms are not used to create it. The drug "Prevenar 13" is available in a cardboard box. Each copy of the product contains a set of a glass syringe with a white suspension for a single use of 0.5 ml, an injection needle and detailed instructions for vaccination.
"Prevenar 13" is indicated for immunization of infants from 2 months. The vaccinating solution is injected intramuscularly into the anterolateral surface of the thigh. In children aged 2 years and older, the area of application of the drug is the brachial deltoid muscle. This vaccine is prohibited for intravenous use. It contains the following active ingredients:
- pneumococcal conjugates;
- polysaccharides of 13 serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F;
- carrier protein CRM197.
Along with this, in the manufacture of Prevenar 13, additional substances are used, such as:
- aluminum phosphate;
- sodium chloride;
- succinic acid;
- polysorbate.
Due to the content of diphtheria protein, the drug remains in the child's blood for as long as it takes to develop stable immunity to pneumococci. Pneumococcal vaccination was included in the National Immunization Schedule in 2014, and since that time it has been considered mandatory. In accordance with the approved schedule, the Prevenar vaccine is administered to all children in the absence of any restrictions with the consent of the parents.
Vaccination with the drug "Prevenar" is done according to a certain scheme. Timing and methods of immunization for convenience are presented in the form of a table.
Child's age (in months) Number of procedures Intervals and dosage 2–6 3+1/2+1 Individual immunization implies a three-fold administration of the drug with intervals between procedures of at least 1 month. Revaccination is carried out at the age of 11-15 months. With mass immunization (at the expense of the state), the solution is administered twice. The interval between injections is 2 months. Revaccination in this case is carried out when the baby reaches 11-15 months. 7–11 2+1 Double use of the drug with a monthly interval between procedures. To consolidate the result, revaccination is indicated after the baby is 2 years old. 12–23 1+1 Double vaccination with a two-month interval between the administration of the drug 24 and over 1 Single Immunization There is an opinion that immunization against infections caused by pneumococci, children over 6 years of age is inappropriate. This is due to the fact that in babies of this age, the immune system is already fully formed, so they can easily tolerate the attack of pneumococci that have become active in their body.
A distinctive feature of the Prevenar vaccine is its compatibility with many other vaccinating preparations. For this reason, different types of vaccinations are often combined.
Contraindications to the use of "Prevenar"
Despite being well tolerated in children, the Prevenar pneumococcal vaccine has a number of contraindications, most of which are relative. This drug is temporarily prohibited for use when:
- exacerbation of any of the chronic diseases;
- acute course of diseases, including if the baby is diagnosed with SARS, etc .;
- an increase in body temperature, including slight hyperthermia.
You can vaccinate a baby only after a full recovery. Absolute contraindications for vaccination with Prevenar 13 include:
- individual intolerance to its components;
- allergic reactions to the previous administration of this solution;
- age up to 2 months.
Preparing the child and parents for vaccination
Vaccination with Prevenar will be successful if you properly prepare for the procedure. Preparation for immunization implies compliance with the following rules:
In order for the baby not to be afraid of injections, you can take his favorite toy to the hospital. In addition, before the procedure, parents should check the expiration date of the drug and make sure the integrity of its packaging. It should be borne in mind that Prevenar 13 cannot be frozen, so if a health worker takes it out of the freezer, the use of such an instance should be discarded. The drug is also considered unsuitable for use in cases where, when shaken, the contents of the syringe acquire a non-uniform color with foreign inclusions.
In addition, before the procedure, parents need to ensure that the vaccine used is stored in the refrigerator, and that the medical staff perform manipulations with sterile instruments and disposable rubber gloves.
Controlling the immunization process will protect the baby from the development of complications.
How is Prevenar vaccinated?
Vaccination with Prevenar 13 is done only by specially trained health workers. The package is opened only after checking the expiration date of the drug. The place where the needle will be inserted is treated with a disinfectant. Then the syringe with the vaccine is thoroughly shaken until a solution of a uniform white consistency is formed, after which this liquid is immediately injected into the child.
The area of administration of "Prevenar" depends on the age of the small patient. If the child to be vaccinated is already 2 years old, the injection is given in the deltoid brachial muscle. For younger babies, the needle is inserted into the anterolateral surface of the thigh at the level of the middle third. In the latter case, this area for injection was not chosen by chance. In the event of complications, it is more convenient for children to apply a tourniquet to this area.
Post-vaccination reaction
Normal
In children, on the introduction of the drug "Prevenar" within the normal range, a reaction may occur in the form of:
The listed symptoms accompany the use of many analogues of the described vaccinating drug and are detected in 1/5 of the babies. These phenomena, as a rule, disappear on their own within 1-3 days from the moment of vaccination. If after 24 hours after the introduction of the vaccine, the reaction increases, and the baby's condition worsens, you should immediately consult a doctor.
Side effects and complications
According to medical statistics, the side effects of using the described vaccine preparation are extremely rare and occur in no more than 1% of cases. At the same time, only in isolated situations, children need medical help to eliminate the negative effects of this remedy.
Before the introduction of this vaccine, the doctor must warn parents about the possibility of developing the following side effects:
If you notice one of these symptoms, you should immediately call an ambulance. In this case, self-treatment, as well as the slightest delay, can lead to serious consequences up to a tragic outcome.
Rules of conduct after vaccination
The post-vaccination stage requires strict adherence to a number of rules. If they are ignored, the likelihood of developing serious complications increases. At the same time, for a certain time, the diet and daily routine of the baby should be adjusted. In addition, in order to avoid re-infection, you need to properly care for the injection site. All these simple rules will help protect the baby from the development of undesirable consequences and accelerate the formation of immunity against infections caused by pneumococci.
Insertion site care
- During the first day, it can not be wetted.
- After 24 hours from the moment of administration of the vaccinating preparation, the injection site is allowed to be washed with warm boiled water. It can also be wiped with wet wipes. In this case, you need to use only those skin-cleansing products that do not have antibacterial properties.
- It is forbidden to lubricate the injection site with brilliant green, iodine, potassium permanganate or antiseptic solutions.
- This area cannot be sealed with a band-aid or a bandage bandage is applied to it, it must be open.
In addition, parents should ensure that the baby does not comb or scratch the needle insertion site. This can only aggravate the situation, causing irritation of the skin and, as a result, secondary infection.
Mode restrictions
In addition, it is necessary to exclude his contact with infectious patients. Against the background of the general malaise of the child, accompanied by the formation of immunity against diseases caused by pneumococci, infection with other infections can provoke dangerous complications.
Features of the diet
The diet of the baby at the post-vaccination stage has certain features. During the first few days after the introduction of the drug "Prevenar 13" it is recommended to observe the following rules:
- you can not change the feeding regimen and diet within 1 week after vaccination;
- at this time, the baby should be provided with plenty of fluids.
In case of partial or complete refusal of the child to eat for a long time, you should immediately show it to the doctor. Babies without proper nutrition lose weight quickly, which is an extremely dangerous phenomenon that requires urgent action.
Prevenar 13 is a drug that is used to prevent pneumococcal disease. It helps prevent pneumonia, meningitis, etc. Reviews about the vaccination are mixed, so parents are interested in what Dr. Komarovsky thinks about it.
The vaccine is a suspension for intramuscular administration. The main active substances are pneumococcal conjugates, as well as additional components. The vaccine promotes the production of antibodies to capsular polysaccharides, therefore protecting the body from specific microorganisms. It is stored for 3 years at a temperature of 2 to 8 degrees. The vaccine must not be frozen.
Method of administration
The drug is injected into the muscle in an amount of 0.5 ml. Up to two years, the vaccine is given in the upper thigh, and after two years - in the deltoid muscle. Before use, the syringe with the substance is shaken well to obtain a uniform consistency. If after this manipulation the contents of the syringe did not acquire the desired color, small particles of unknown origin appeared, the vaccine cannot be used.
Attention! "Prevenar 13" must not be injected into a vein and the gluteal muscle!
Dr. Komarovsky advises mothers to use the same drug to protect the child's body. If you have started a Prevenar 13 series of vaccinations, then you should also use it for subsequent vaccinations.
Contraindications
Main contraindications:
- hypersensitivity to the components that make up the composition;
- infectious diseases that pass in an acute form;
- exacerbation of chronic diseases.
Vaccination can be done only after complete recovery, otherwise it can lead to complications.
The use of Prevenar 13 during pregnancy and lactation is not recommended, since studies on the effect of the drug on the female body and the fetus have not been conducted.
Side effects
- swelling of the injection site;
- sleep disturbance;
- high body temperature;
- irritability.
According to the observations of Komarovsky, children of the first year of life tolerate the vaccine much more easily than older children who are given this drug for the first time. Side effects are more common.
An overdose of Prevenar 13 is not possible, since the vaccine is sold in a syringe in an amount calculated for 1 dose. The medication is released strictly according to the prescription.
Interaction with other medicines
As mentioned above, it is better to carry out a series of vaccinations with the same drug. If Prevenar 13, with which you started vaccinating against pneumococcal infections, is not available, use the vaccine of the same group, but inject it at a different injection site. Dr. Komarovsky, like other pediatricians, claims that this drug is safely used with other vaccines that are included in the immunization calendar, according to age norms.
If you have not vaccinated your baby with Prevenar 13, Komarovsky advises stocking up
INSTRUCTIONS
on the use of a medicinal product for medical use
PREVENAR ® 13
(vaccine pneumococcal polysaccharide conjugated adsorbed, thirteen-valent)
INTERNATIONAL NON-PROPRIETARY OR GROUPED NAME: vaccine to prevent pneumococcal infections
REGISTRATION NUMBER:
PHARMACEUTICAL FORM: suspension for intramuscular injection
Prevenar ® 13 vaccine is a capsular polysaccharide of 13 pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, individually conjugated to the diphtheria protein CRM 197 and adsorbed on aluminum phosphate .
COMPOUND
Composition per dose (0.5 ml):
Active substances :
Pneumococcal conjugates (polysaccharide - CRM 197):
Excipients : aluminum phosphate - 0.5 mg (in terms of aluminum 0.125 mg), sodium chloride - 4.25 mg, succinic acid - 0.295 mg, polysorbate 80 - 0.1 mg, water for injection - up to 0.5 ml.
PREVENAR ® 13 is manufactured in accordance with WHO guidelines for the production and quality control of pneumococcal conjugate vaccines.
DESCRIPTION
Homogeneous suspension of white color.
PHARMACOLOGICAL GROUP: pneumococcal purified polysaccharide antigen conjugated
ATX code: J07AL02
IMMUNOLOGICAL PROPERTIES
The introduction of the vaccine Prevenar ® 13 causes the production of antibodies to capsular polysaccharides Streptococcus pneumoniae, thereby providing specific protection against infections caused by pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F included in the vaccine.
According to the WHO recommendations for new pneumococcal conjugate vaccines, the equivalence of the immune response of Prevenar ® 13 was determined according to three criteria: the percentage of patients who reached the concentration of specific IgG antibodies ³ 0.35 µg/ml; geometric mean concentrations (SGK) of immunoglobulins and opsonophagocytic activity (OPA) of bactericidal antibodies (OPA titer ³ 1:8 and geometric mean titers (GMT)). For adults, a protective level of anti-pneumococcal antibodies has not been determined and serotype-specific OFA (SGT) is used.
The vaccine Prevenar ® 13 includes up to 90% of serotypes that cause invasive pneumococcal infections (IPIs), including those resistant to antibiotic treatment.
Immune response when using three or two doses in a series of primary vaccinations
After the introduction three doses Prevenar ® 13 during the primary vaccination of children under the age of 6 months, a significant increase in the level of antibodies to all vaccine serotypes was noted.
After the introduction two doses during the primary vaccination with Prevenar ® 13 as part of the mass immunization of children of the same age group, there is also a significant increase in antibody titers to all components of the vaccine; for serotypes 6B and 23F, the level of IgG ³ 0.35 μg / ml was determined in a smaller percentage of children. At the same time, a pronounced booster response to revaccination was noted for all serotypes. The formation of immune memory is shown for both of the above vaccination schemes. Secondary immune response to a booster dose in children of the second year of life when using three or two doses in the primary vaccination series are comparable for all 13 serotypes.
When vaccinating premature babies (born at gestational age< 37 недель), включая глубоко-недоношенных детей (родившихся при сроке гестации < 28 недель), начиная с возраста двух месяцев, отмечено, что уровень защитных специфических противопневмококковых антител и их ОФА после законченного курса вакцинации достигали значений выше защитных у 87-100 % привитых ко всем тринадцати включенным в вакцину серотипам.
Immunogenicity in children and adolescents aged 5 to 17 years
Children aged 5 to< 10 лет, которые до этого получили как минимум одну дозу пневмококковой 7-валентной конъюгированной вакцины, а также ранее не вакцинированные дети и подростки в возрасте от 10 до 17 лет, получив по одной дозе вакцины Превенар ® 13, продемонстрировали иммунный ответ на все 13 серотипов, эквивалентный таковому у детей 12-15 месяцев, вакцинированных четырьмя дозами препарата Превенар ® 13.
A single administration of Prevenar ® 13 to children aged 5-17 years can provide the necessary immune response to all serotypes of the pathogen that are part of the vaccine.
Immunogenicity of Prevenar ® 13 vaccine in adults
In adults aged 60-64 years who have not previously received a polysaccharide pneumococcal 23-valent vaccine (PPV23) after receiving Prevenar® 13 or PPV23 vaccines, and in adults aged 50-59 years who received a single dose of Prevenar® 13 vaccine , immunological equivalence was established for 12 serotypes common with PPV23. In addition, 8 serotypes in common with PPV23 and serotype 6A, unique to Prevenar ® 13 vaccine, demonstrated a statistically significantly higher immune response to Prevenar ® 13.
The immune response to Prevenar ® 13 in people aged 50-59 years for all 13 serotypes was equivalent to that of adults aged 60-64 years. Moreover, individuals aged 50-59 years had a statistically higher immune response to 9 of 13 serotypes compared to those aged 60-64 years.
Immune response in adults previously vaccinated with PPV23
In adults aged 70 years and over who were vaccinated once with PPV23 ≥ 5 years ago, Prevenar® 13 was non-inferior to 12 common serotypes compared to PPV23, with 10 common serotypes and serotype 6A immune response to Prevenar® 13 was statistically significantly higher compared to the response to PPV23. It has been shown that Prevenar ® 13 gives a more pronounced immune response compared to PPV23 revaccination.
Clinical efficacy of Prevenar® 13 was demonstrated in the randomized, double-blind, placebo-controlled CAPITA study (more than 84,000 patients) against community-acquired pneumococcal pneumonia (CAP) in adults aged 65 years and older: 45% against the first episode of CAP caused by serotypes overlapping Prevenar ® 13 (invasive and non-invasive); 75% for invasive infections caused by serotypes covered by Prevenar 13.
Immune response in special groups of patients
Patients with the conditions described below are at increased risk of pneumococcal infection. The clinical significance of the immune response induced by Prevenar ® 13 in these groups of patients is currently unknown.
sickle cell anemia
In an open, non-comparative study conducted in France, Italy, the United Kingdom, the United States, Lebanon, Egypt, and Saudi Arabia in 158 children and adolescents aged ≥ 6 and< 18 лет с серповидноклеточной анемией, ранее вакцинированных одной или более дозами ППВ23 как минимум за 6 месяцев до включения в исследование показало, что введение первой дозы Превенар ® 13 при двукратной иммунизации с интервалом 6 месяцев приводило к статистически значимо высокому иммунному ответу (СГК IgG к каждому серотипу, определяемые методом иммуноферментного анализа (ИФА), и СГТ опсонофагоцитарной активности (ОФА СГТ) к каждому серотипу). После ведения второй дозы иммунный ответ был сопоставим с таковыми после первой дозы препарата..
HIV infection
HIV-infected children and adults with a CD4 count ≥ 200 cells/μL (mean 717.0 cells/μL), viral load< 50 000 копий/мл (в среднем 2090,0 копий/мл), с отсутствием активных СПИД-ассоциированных заболеваний и ранее не получавшие вакцинации пневмококковой вакциной, получали 3 дозы Превенар ® 13. Показатели IgG СГК и ОФА были достоверно выше после первой вакцинации Превенар ® 13 по сравнению с довакцинальным уровнем. На вторую и третью дозы (через 6 и 12 месяцев) развивался более высокий иммунный ответ, чем после однократной вакцинации Превенар ® 13..
Hematopoietic stem cell transplantation
Children and adults who underwent allogeneic hematopoietic stem cell transplantation (HSCT) aged ≥ 2 years with complete hematological remission of the underlying disease or with satisfactory partial remission in the case of lymphoma and myeloma received three doses of Prevenar 13 at least 1 month apart between doses. The first dose of the drug was administered 3-6 months after HSCT. The fourth (booster) dose of 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. Titers of functionally active antibodies (OPA GT) were not determined in this study. The introduction of Prevenar ® 13 caused an increase in SGC serotype-specific antibodies after each dose. The immune response to the booster dose of Prevenar ® 13 was significantly higher for all serotypes compared to the response to the primary immunization series.
Loading...