Menaktra - Instructions For The Use Of The Vaccine, Reviews Of Vaccination, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Menaktra

Menaktra: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Use in the elderly
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Menactra

ATX code: J07AH08

Active ingredient: vaccine for the prevention of meningococcal infections (Meningococcal vaccine)

Manufacturer: Sanofi Pasteur Inc. (Sanofi Pasteur, Inc.) (USA); Sanofi Pasteur S. A. (Sanofi Pasteur, SA) (France)

Description and photo updated: 17.07.2018

Prices in pharmacies: from 3821 rubles.

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Menactra is a vaccine for the prevention of diseases caused by meningococci.

Release form and composition

Dosage form - solution for intramuscular administration: colorless transparent or slightly turbid (0.5 ml each in 3 ml transparent glass vials, sealed with a cork and rolled up with an aluminum cap, in a cardboard box of 1 or 5 vials and instructions for the use of Menaktra).

Composition of 1 dose of the vaccine (0.5 ml of solution):

• active substances: monovalent meningococcal conjugates (polysaccharide + carrier protein), in particular polysaccharide serogroup A *, polysaccharide serogroup C *, polysaccharide serogroup Y * and polysaccharide serogroup W-135 * - 4 μg each;
• auxiliary components: sodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate, sodium chloride, water for injection.

* Each polysaccharide is conjugated with diphtheria toxoid, the protein content of which is about 48 μg per inoculation dose.

Pharmacological properties

Menactra is a vaccine containing a solution of purified Neisseria meningitidis group A, C, Y and W-135 capsular polysaccharides, individually conjugated to a carrier protein (purified Corynebacterium diphtheriae toxoid).

Neisseria meningitidis is the causative agent of meningococcal infection, including meningitis and septicemia (a number of serotypes of this pathogen have been identified). Menactra promotes the production of specific antibodies in the body that have bactericidal activity against capsular polysaccharides of serogroups included in the vaccine.

Clinical studies to study the effectiveness of Menactra have not been conducted, since the production of serum bactericidal antibodies (SBA) is considered an indicator of the effectiveness of meningococcal vaccines.

The immunological properties of Menaktra vaccine were studied in three clinical studies in children aged 9-18 months, in four clinical studies in children 2-10 years old and in six clinical studies in patients aged 11 to 55 years. Immunogenicity was assessed by the level of functional antibodies, which were determined using bactericidal analysis of serum (BAS) using rabbit complement.

The primary immunological profile has been studied in clinical studies in children 2–10 years old. The immune response was assessed immediately prior to the administration of the Menactra dose and 28 days after vaccination. There was a significant increase in the geometric mean of the titers (GST) of bactericidal antibodies. With initially undetectable SBA titers (<1 ÷ 8), 86-100% of participants in all serogroups showed seroconversion - an increase in antibody titers by 4 or more times 28 days after vaccine administration.

Menaktra is able to induce the development of immunological memory after primary vaccination, which has been documented in clinical studies conducted in both children and adults.

Based on the results of three clinical trials in children aged 9-18 months who received the vaccine once or twice in isolation or simultaneously with other pediatric vaccines [MMRV (measles, mumps, rubella and chickenpox vaccine) or PCV (pneumococcal conjugate vaccine)], it was confirmed that in the majority of children after a two-fold administration of Menaktra (including simultaneously with other vaccines), an increase in the SBA titer ≥ 1 ÷ 8 to all serogroups of the vaccine is noted. In 91% of participants, with a separate two-fold administration of Menactra, an increase in SBA titer ≥ 1 ÷ 8 was observed for serogroups A, C, Y; in 86% of children - to serogroup W-135. An increase in SBA titer ≥ 1 ÷ 8 was observed in most children who received the second dose of Menactra simultaneously with PCV or MMR, or MMR + vaccine for the prevention of infections,caused by Haemophilus influenzae: in more than 90% of participants - to serogroups A, C and Y; more than 81% of children have serogroup W-135. The values of CGT SBA for all serogroups of meningococci included in the vaccine became higher than the initial values.

In studies of the vaccine in children 11-18 years old, a pronounced immune response to a single administration of Menactra was confirmed. The values of SGT SBA at 28 days after vaccination were significantly higher than the baseline. Moreover, in 98-100% of participants with initially undetectable antibody titers (<1-8) after 28 days, an increase in the SBA titer to all serogroups of the vaccine was observed 4 or more times. Such data indicate the high immunogenicity of Menactra in this age group.

In the course of analysis by serogroups in adults, it was found that in 93-100% of participants in whom the antibody titer was not initially determined (<1 ÷ 8), 28 days after vaccination, an increase in the SBA titer was noted for all serogroups of the pathogen included in the vaccine, in 4 or more times. In each of the three studies, the immunological response to Menactra administration was found to be similar when evaluating groups for race, age and sex.

There are no data on the kinetics of the initial response to the administration of Menactra, however, given the experience of using other conjugated and polysaccharide vaccines, the development of immune protection is possible within 7-10 days after vaccination.

Clinical studies have shown Menactra's ability to induce the formation of immune memory after primary vaccination. In one of the studies, it was found that 3 years after a single vaccination, the persistence of bactericidal antibodies in the blood is higher than in the group of individuals vaccinated with a quadrivalent polysaccharide meningococcal vaccine against serogroups A, C, Y and W-135. In the group vaccinated with Menactra, a higher concentration of SBA was revealed, and a higher percentage of patients had specific highly avid antibodies, which confirms the formation of immune memory.

Indications for use

Menaktra vaccine is used for the prevention of invasive meningococcal disease caused by Neisseria meningitidis groups A, C, Y and W-135 in patients aged 9 months to 55 years.

Contraindications

• acute infectious and non-infectious diseases or exacerbation of chronic diseases (vaccination is possible after recovery or in remission);
• known hypersensitivity to any component of Menactra or a history of hypersensitivity reactions to the administration of other vaccines containing the same components.

Menaktra, instructions for use: method and dosage

Menaktra is administered intramuscularly. The choice of the injection site depends on the age of the vaccinated: it is recommended to inject the solution into the anterolateral region of the thigh for children of 9–12 months, for children over 12 years old and for adults - into the deltoid muscle of the shoulder.

One vial contains 1 dose of the vaccine (0.5 ml).

Children aged 9–23 months are shown the introduction of two doses of the drug with a minimum interval of 3 months.

For children from 2 years old, adolescents and adults up to 55 years old, a single administration of one dose of Menactra is sufficient.

Immunization Precautions:

• before the introduction of the vaccine, the doctor must take all the necessary precautions aimed at preventing the development of severe side effects: studying the patient's vaccination history, establishing the presence of contraindications to vaccination, assessing the current state of health of the vaccinated;
• the introduction of the vaccine should be carried out by a qualified medical specialist in an office where anti-shock therapy is provided (for example, injectable glucocorticosteroids and epinephrine hydrochloride solutions);
• in connection with the likelihood of fainting in the vaccinated, it is necessary to provide measures to prevent injuries associated with falling in case of loss of consciousness, and to provide medical assistance in case of fainting.

Side effects

In studies, Menactra's adverse reactions varied depending on the age of the vaccinated.

In children 9–18 months of age, within 7 days after immunization, tenderness and tenderness at the injection site were most common. In children 2–10 years old, redness and soreness at the injection site, diarrhea, anorexia, drowsiness and irritability. In adolescents 11–18 years old and adults 18–55 years old - soreness at the injection site, increased fatigue and headache.

Classification of the frequency of side effects according to the recommendations of the World Health Organization: very often - 10%, often - from ≥ 1 to <10%, infrequently - from ≥ 0.1 to <1%, rarely - from ≥ 0.01 to <0.1 %, very rarely - <0.01%, frequency unknown - from the available data, the frequency cannot be determined.

Possible side effects in children 9-18 months of age:

• gastrointestinal tract: very often or often - vomiting;
• nervous system: very often - drowsiness;
• metabolism: very often - loss of appetite;
• reactions at the injection site: very often - soreness, edema, erythema at the injection site;
• others: fever, abnormal crying, irritability.

Most of these side reactions were mild and lasted no more than 3 days.

Possible side effects in children 2-10 years old:

• gastrointestinal tract: very often - diarrhea; often - vomiting;
• nervous system: very often or often - drowsiness;
• metabolism: very often or often - decreased appetite;
• reactions at the injection site: very often - soreness and induration at the injection site; very often or often - redness and swelling at the injection site;
• skin and subcutaneous tissues: often - skin rashes, urticaria;
• musculoskeletal and connective tissue: often - arthralgia;
• others: fever, irritability.

Most of these adverse reactions were mild.

Possible side effects in vaccinated 11–55 years:

• gastrointestinal tract: very often or often - diarrhea; often - vomiting;
• nervous system: very often - headache;
• metabolism: very often or often - decreased appetite;
• reactions at the injection site: very often - soreness, swelling, redness and induration at the injection site;
• skin and subcutaneous tissue: often - skin rashes;
• musculoskeletal and connective tissue: very often - arthralgia;
• others: very often - general malaise, increased fatigue; often - fever, chills.

Most of these adverse reactions were mild.

During the post-marketing study, the following side effects were registered (the frequency of their development and the connection with the administration of Menactra have not been established):

• immune system: hypersensitivity reactions such as difficulty breathing, stridor breathing, swelling of the upper respiratory tract, skin redness, urticaria, pruritus, anaphylactoid reactions, anaphylactic shock, decreased blood pressure;
• nervous system: dizziness, loss of consciousness (due to dysregulation of the autonomic nervous system), facial paralysis, paresthesia, transverse myelitis, convulsions, Guillain-Barré syndrome, acute disseminated encephalomyelitis.

The risk of developing Guillain-Baret syndrome (GBS) after vaccination was assessed in a retrospective cohort study in the United States of America. It used an electronic database of medical services for 9,578,688 patients aged 11 to 18 years. Of these, 1,431,906 patients (15%) received the Menaktra vaccine. 72 episodes with confirmed GBS were reported, but none of the patients had been immunized with Menaktra vaccine within 42 days of symptom onset. Another 129 potential cases of GBS were described, but these were not confirmed or were excluded from the analysis due to insufficient or lack of medical information. In an analysis that took into account missing data,the additional risk of GBS was estimated as 0–5 additional cases of Guillain-Baret syndrome per 1,000,000 vaccinated within 6 weeks after vaccination.

Overdose

No information available.

special instructions

Immunization is especially indicated with a high risk of meningococcal disease, in particular, it is recommended for the following patient groups:

• persons who have had direct contact with patients infected with meningococci of serogroups A, C, Y or W-135 (in the family or in closed institutions);
• persons with functional or anatomical asplenia;
• persons with deficiency of properdin and complement components;
• students, especially those living in hostels or apartment hotels;
• employees of clinical laboratories, research and industrial enterprises regularly exposed to meningitidis in solutions that can form an aerosol;
• tourists and people traveling to areas that are hyperendemic for meningococcal infection, for example, in sub-Saharan Africa;
• conscripts and recruits.

Menaktra vaccine is not intended to prevent meningitis caused by organisms other than N. meningitidis or to prevent invasive meningococcal infection caused by meningococcal serogroup B.

The vaccine should not be administered subcutaneously, intradermally or intravenously, as no safety data are available.

It is forbidden to mix Menaktra solution in the same syringe with any other medicinal substances and vaccines.

In people with impaired immune status and patients receiving immunosuppressive therapy, it is possible that the immune response to the administration of meningococcal vaccine is reduced.

The use of Menactra in patients with bleeding disorders and thrombocytopenia has not been studied, therefore, before vaccination, the doctor must assess the balance between the benefits of vaccination and the risk of bleeding.

Cases of the development of Guillain-Bare syndrome have been described, which were associated with immunization in time. Patients with a previously diagnosed condition may have an increased risk of developing GBS after Menactra is administered. Therefore, the decision on the benefits of vaccination is made by the doctor individually.

Before immunization, the healthcare professional should inform the patient, parents or guardians of the vaccinated person about the possible risks associated with the introduction of meningococcal vaccine.

Not all 100% of those vaccinated may develop protective immunity.

Influence on the ability to drive vehicles and complex mechanisms

No studies have been conducted on the influence of Menactra on the reaction rate of the vaccinated and his ability to concentrate.

Application during pregnancy and lactation

In studies conducted on animals, there was no evidence of a negative effect of the vaccine on the course of pregnancy and the process of childbirth, intrauterine and postnatal development of the fetus / child. However, there have been no studies in pregnant women and there is limited post-marketing experience with vaccination. In this regard, the introduction of Menactra to pregnant women is not recommended, except in cases of extreme necessity (for example, during an outbreak of meningococcal infection or before traveling to an area endemic for meningococcal infection), while the doctor must carefully assess the expected benefits and possible risks.

Whether the components of the vaccine pass into breast milk is currently unknown. In animal studies, antibodies to polysaccharides were found in young breastfed mice. At the same time, no negative impact of the vaccine on the development of offspring was revealed. However, the effects in infants of the first year of life, whose mothers were vaccinated during lactation, have not been studied. For this reason, the physician must assess the benefits and risks in each case individually.

Pediatric use

Vaccination is recommended for children over 9 months of age.

Use in the elderly

Vaccination is recommended for patients under the age of 55.

Drug interactions

There is an experience of combined use of Menaktra with a polysaccharide vaccine for the prevention of typhoid fever and an adsorbed vaccine containing tetanus and diphtheria toxoid in patients 18–55 years old and 11–17 years old, respectively.

In children under 2 years of age, Menaktra was used simultaneously with one or more vaccines, such as pneumococcal conjugate vaccine (PCV), vaccine to prevent chickenpox, vaccine to prevent viral hepatitis A, vaccine to prevent measles, mumps and rubella.

There is no data that would allow assessing the degree of safety and immunogenicity of Menactra when used simultaneously with DPT-containing vaccines in children aged 18 months. There are known cases of a decrease in pneumococcal antibodies against some serotypes contained in the 7-valent pneumococcal conjugate vaccine (PCV7), with the simultaneous administration of Menaktra.

BCG (against tuberculosis) vaccine should not be used concurrently with the vaccine for the prevention of diseases caused by meningococci.

When administering multiple vaccines together, always use separate syringes and select different injection sites.

Analogs

Analogues of Menactra are Meningococcal group A vaccine polysaccharide dry, Menveo, Mentsevax ACWY, Menugate, Polysaccharide meningococcal vaccine A + C.

Terms and conditions of storage

Keep out of reach of children at 2-8 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Menactra

According to reviews, Menaktra is a high-quality and effective vaccine that protects against 4 types of meningococcal infection. It is well tolerated and does not cause serious side effects. Despite the high, in the opinion of patients, the cost, many consider vaccination advisable, especially given the fact that from the age of 2 years, a single dose of one dose is sufficient.

The price of Menaktra in pharmacies

On average, the price of Menaktra is 3748 rubles. for 1 bottle (1 dose).

Menaktra: prices in online pharmacies

Drug name Price Pharmacy

Menaktra Vaccine meningococcal solution for intramuscular administration 0.5 ml 1 pc. RUB 3821 Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!