Menactra^® (Solution) Instructions for Use

Marketing Authorization Holder

Sanofi Pasteur, Inc. (USA)

Manufactured By

Sanofi Pasteur, Inc. (USA)

Packaging and Quality Control Release

SANOFI PASTEUR, Inc. (USA)

Or

NANOLEK, LLC (Russia)

Contact Information

SANOFI RUSSIA JSC (Russia)

ATC Code

J07AH08 (Meningococcus A, C, Y, W-135 purified polysaccharide antigens tetravalent conjugated)

Active Substance

Polysaccharide vaccine for prevention of meningococcal infection of serogroups A, C, W, Y conjugated (Grouping name)

Dosage Form

Menactra®

Solution for intramuscular injection 1 dose (0.5 ml): vial 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection colorless transparent or slightly opalescent.

Excipients: sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate, water for injections.

0.5 ml (1 dose) – vials made of transparent borosilicate glass (type I) with a capacity of 3 ml (1) – cardboard packs.
0.5 ml (1 dose) – vials made of transparent borosilicate glass (type I) with a capacity of 3 ml (5) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of meningococcal infections of serogroups A, C, W, Y, polysaccharide, conjugated

Pharmacotherapeutic Group

Vaccine for the prevention of meningococcal infection

Pharmacological Action

Mechanism of action

The causative agent of meningococcal infection, including meningitis and septicemia, is the bacterium Neisseria meningitidis; several serogroups of the pathogen are distinguished.

Administration of the Menactra^® vaccine induces the production of specific antibodies with bactericidal activity against the capsular polysaccharides of the meningococcal pathogen serogroups included in the vaccine (A, C, Y and W-135).

Immunological efficacy

Clinical studies on the efficacy of meningococcal vaccines are not conducted due to the relatively low incidence of meningococcal infection, therefore the production of serum bactericidal antibodies (SBA) is considered an indicator of the efficacy of meningococcal vaccines.

The immunological properties of the Menactra^® vaccine were studied in 3 clinical trials in children aged 9-18 months inclusive, in 4 clinical trials in children aged 2-10 years inclusive, and in 6 clinical trials in individuals aged 11-55 years inclusive.

Immunogenicity was assessed by the level of functional antibodies determined by SBA assay.

Immunogenicity in children aged 9 to 23 months inclusive

Results from 3 clinical trials involving approximately 2250 children aged 9 to 18 months inclusive with single or double administration of the Menactra^® vaccine alone or concomitantly with other pediatric vaccines (pneumococcal conjugate vaccine (PCV) or measles, mumps, rubella and varicella vaccine (MMRV)) confirmed that the majority of participants in the groups with two doses of the Menactra^® vaccine, when used alone or concomitantly with other pediatric vaccines, showed an increase in SBA titer ≥1:8 against all vaccine serogroups.

In ≥91% and ≥86% of participants in the group with separate two-dose administration of the Menactra^® vaccine, an increase in SBA titer ≥1:8 was observed against serogroups A, C, Y and against serogroup W-135, respectively.

After administration of the second dose of Menactra^® concomitantly with PCV or with MMRV (or MMRV + vaccine for the prevention of infections caused by Haemophilus influenzae type b), the majority of study participants showed an increase in SBA titer ≥1:8 (in >90% of study participants against serogroups A, C and Y, in >81% of participants against serogroup W-135).

The geometric mean titers of SBA after vaccination against all four meningococcal serogroups included in the vaccine were high.

Immunogenicity in children aged 2 to 10 years inclusive, not previously immunized with a vaccine for the prevention of meningococcal infection

The primary immunological profile of the vaccine was studied in clinical trials involving more than 750 participants aged 2 to 10 years.

The immune response was assessed 28 days after administration of the Menactra^® vaccine (compared to baseline antibody levels before vaccination).

Study participants showed a significant increase in geometric mean SBA titers.

In 86-100% of participants with initially undetectable SBA titer values (<1:8), seroconversion to antigens of all pathogen serogroups was noted, defined as a 4-fold (or greater) increase in antibody titers 28 days after vaccination compared to pre-vaccination antibody titers.

Immunogenicity in individuals aged 11 to 18 years inclusive

Results from studies involving approximately 1400 participants aged 11 to 18 years confirmed a pronounced immune response to a single administration of the Menactra^® vaccine.

The geometric mean SBA titers on day 28 after vaccination were significantly higher than baseline.

Furthermore, in 98-100% of adolescents who initially had undetectable antibody titers (<1:8), a 4-fold (or greater) increase in SBA titer against all pathogen serogroups included in the vaccine was observed by day 28.

The results obtained indicate high immunogenicity of the vaccine in adolescents.

Immunogenicity in individuals aged 18 to 55 years inclusive

The immunogenicity of the Menactra^® vaccine was demonstrated in three clinical trials involving more than 3000 adolescents and adults.

Vaccine immunogenicity was assessed immediately before and 28 days after administration of a single dose of the Menactra^® vaccine.

The geometric mean SBA titers on day 28 after vaccination were significantly higher than baseline.

In 93-100% of participants who initially had undetectable antibody titers (<1:8), a 4-fold (or greater) increase in SBA titer against all pathogen serogroups included in the vaccine was observed by day 28.

The immunogenicity of the Menactra^® vaccine was similar among individuals of different ages, races, and genders.

Immunogenicity in individuals previously immunized with a vaccine for the prevention of meningococcal infection serogroup C

The ability of the Menactra^® vaccine to induce a booster immune response to serogroup C polysaccharides, as well as to primarily immunize against serogroup A, Y and W-135 polysaccharides, was demonstrated in children aged 3 to 5 years who had previously been immunized with a vaccine for the prevention of meningococcal infection serogroup C in the first year of life.

Kinetics of the immune response

There are no data on the kinetics of the initial response to the administration of the Menactra^® vaccine; however, as with other polysaccharide and conjugate vaccines, immune protection is usually formed 7-10 days after vaccination.

Assessment of immunological memory

The ability of the Menactra^® vaccine to induce immunological memory after primary vaccination is confirmed by data from clinical trials in children and adults.

One study demonstrated that the persistence of bactericidal antibodies in the blood 3 years after a single administration of the Menactra^® vaccine was higher compared to the group vaccinated with a single immunization with a non-conjugated quadrivalent polysaccharide meningococcal vaccine against serogroups A, C, Y and W-135.

In the group vaccinated with the Menactra^® vaccine, higher SBA concentrations were observed, as well as a higher proportion of individuals with specific high-avidity antibodies, indicating the formation of immune memory.

Immunogenicity in adolescents and adults after revaccination

In a clinical trial conducted in the USA, 834 people were revaccinated once with the Menactra^® vaccine 4-6 years after vaccination.

Before revaccination, the proportion of participants with SBA titer <1:8 was 64.5%, 44.2%, 38.7% and 68.5% for serogroups A, C, Y and W-135, respectively.

In the subgroup of study participants who were assessed for response on day 6 after revaccination (n=112), 86.6%, 91.1%, 94.6% 92.0% of patients achieved ≥4-fold increase in SBA titer for serogroups A, C, Y and W-135, respectively.

The proportions of study participants (n=781) who achieved a ≥4-fold increase in SBA titer on day 28 after revaccination were 95.0%, 95.3%, 97.1% and 96% for serogroups A, C, Y and W-135, respectively.

The proportion of study participants who achieved an SBA titer ≥1:8 on day 28 was >99% for each of the 4 serogroups.

Efficacy and safety when used concomitantly with other vaccines

In a double-blind, randomized, controlled clinical trial in 945 individuals aged 18-55 years, a polysaccharide vaccine for the prevention of typhoid fever was used concomitantly with the Menactra^® vaccine or one month after administration of the Menactra^® vaccine.

Antibody levels to the components of both vaccines, measured on day 28 after the respective vaccination, were similar in both study groups.

In a double-blind, randomized, controlled clinical trial in 1021 individuals aged 11-17 years, the Menactra^® vaccine was used concomitantly with an adsorbed diphtheria (reduced antigen content) and tetanus vaccine intended for use in older children, adolescents and adults, or one month after administration of the said diphtheria and tetanus vaccine.

Antibody levels to the components of both vaccines were measured on day 28 after the respective vaccination.

The proportion of study participants who achieved a ≥4-fold increase in SBA titer to serogroups C, Y and W-135 was higher with concomitant vaccine use (86-96%) than with administration of the Menactra^® vaccine one month after the adsorbed diphtheria (reduced antigen content) and tetanus vaccine intended for use in older children, adolescents and adults (65-91%).

Antibody production levels to the tetanus and diphtheria components were similar in both study groups.

In a randomized clinical trial in 1345 adolescents aged 11 to 17 years inclusive, concomitant use of the Menactra^® vaccine and the adsorbed diphtheria (reduced antigen content), pertussis (acellular, reduced antigen content) and tetanus vaccine showed a similar safety profile and good tolerability both with concomitant use and with separate administration.

Concomitant use of these two vaccines did not reduce the subsequent production of antibodies to all 4 meningococcal serogroups A, C, Y and W-135, compared to separate administration.

Geometric mean antibody titers to pertactin (PRN) and fimbrial agglutinogens types 2 and 3 (FIM) were lower when the adsorbed diphtheria (reduced antigen content), pertussis (acellular, reduced antigen content) and tetanus vaccine was administered simultaneously with the Menactra^® vaccine than in the case of separate administration of the said two vaccines.

Given the strong immune response to all pertussis antigens in the clinical trial groups and in the absence of accepted serological correlates of protection against pertussis, the clinical significance of the somewhat reduced antibody level to the pertussis component is unknown.

In a randomized, multicenter, parallel-group clinical trial in children aged 4 to 6 years inclusive, the Menactra^® vaccine was used in the following three groups: the Menactra^® vaccine 30 days after concomitant use of inactivated poliovirus vaccine (IPV) with the diphtheria, tetanus, pertussis (acellular) vaccine; IPV 30 days after concomitant use of the Menactra^® vaccine with the diphtheria, tetanus, pertussis (acellular) vaccine; the diphtheria, tetanus, pertussis (acellular) vaccine 30 days after concomitant use of IPV and the Menactra^® vaccine.

When the Menactra^® vaccine was administered 30 days after concomitant administration of IPV with the diphtheria, tetanus, pertussis (acellular) vaccine, a reduction in antibody production to all 4 meningococcal serogroups was observed compared to concomitant administration of the Menactra^® vaccine and IPV 30 days before administration of the diphtheria, tetanus, pertussis (acellular) vaccine.

With concomitant administration of the Menactra^® vaccine with the diphtheria, tetanus, pertussis (acellular) vaccine, non-inferior SBA titers to serogroups A, C and W-135 were observed compared to the group with concomitant use of the Menactra^® vaccine and IPV.

Regarding serogroup Y, somewhat lower SBA titers were observed.

The Menactra^® vaccine demonstrated a similar safety profile and good tolerability both with concomitant use and with separate administration.

Concomitant administration of the Menactra^® vaccine with HPV vaccines was evaluated in two studies.

In one study, the Menactra^® vaccine was administered to women aged 11 to 18 years concomitantly only with the bivalent human papillomavirus vaccine (types 16 and 18) with AS04 adjuvant (HPV2) and also concomitantly with the adsorbed diphtheria (reduced antigen content), pertussis (acellular, reduced antigen content) and tetanus vaccine.

In another study, the Menactra^® vaccine was administered to women and men aged 10 to 17 years simultaneously with the quadrivalent human papillomavirus vaccine (types 6, 11, 16 and 18) (HPV4) and the adsorbed diphtheria (reduced antigen content), pertussis (acellular, reduced antigen content) and tetanus vaccine.

In both studies, the safety profiles of the vaccines after concomitant use were similar to those observed with separate administration.

Simultaneous administration of the Menactra^® vaccine and the adsorbed diphtheria (reduced antigen content), pertussis (acellular, reduced antigen content) and tetanus vaccine with HPV vaccines did not affect the immune responses to any of the antigens of these vaccines.

In an active-controlled clinical trial in 1179 children under 2 years of age, the Menactra^® vaccine was used concomitantly with one or more of the following vaccines during the administration of the second dose at 12 months of age: pneumococcal 7-valent conjugate vaccine (PCV7), measles, mumps, rubella vaccine (with or without varicella component), varicella vaccine, hepatitis A vaccine, or vaccine for the prevention of infections caused by Haemophilus influenzae type b.

The Menactra^® vaccine and the listed vaccines had similar safety profiles when administered concomitantly or separately at 12 months of age.

The immunogenicity profiles of the Menactra^® vaccine and the measles, mumps, rubella vaccine (with or without varicella component) or the vaccine for the prevention of infections caused by Haemophilus influenzae type b were also similar when administered concomitantly or separately.

Titers of pneumococcal antibodies to 3 serotypes contained in PCV7 (4, 6B and 18C) were reduced after simultaneous administration of the Menactra^® vaccine and the PCV7 vaccine.

Preclinical safety data

Data obtained from animal studies demonstrated no unexpected effects or toxicity to target organs.

A toxicological study in rats with single or double intramuscular administration of the full human dose revealed no toxicological effects.

Pharmacokinetics

Pharmacokinetic studies have not been conducted.

Indications

• Prevention of invasive forms of meningococcal infection caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals aged from 9 months to 55 years inclusive.

ICD codes

Dosage Regimen

The vaccine should be administered intramuscularly, taking into account the age of the vaccinee: to children aged 9 to 12 months – into the anterolateral area of the thigh; to children from 12 months and older and adults – into the deltoid muscle of the shoulder.

Do not administer the vaccine intravascularly.

Before administration, it is necessary to ensure that the needle has not entered a blood vessel.

Vaccination is carried out with one dose of 0.5 ml.

Primary immunization

In children aged 9 to 23 months inclusive, the vaccination course with the Menactra^® vaccine consists of 2 injections of one dose of the vaccine (0.5 ml) with an interval of at least 3 months.

In individuals aged 2 to 55 years inclusive, vaccination is carried out once with a dose of 0.5 ml.

Revaccination

If the risk of meningococcal infection persists, a single revaccination can be carried out if at least 4 years have passed since the administration of the previous dose.

Instructions for preparation of the vaccine for administration and subsequent waste disposal

Before use, the vaccine vial should be visually inspected for the presence of foreign particles and/or uncharacteristic coloration. In any of these cases, the vaccine should not be used.

The plastic flip-off cap should be removed, and using a suitable syringe and needle, 0.5 ml of the solution should be drawn, ensuring before administration that there are no air bubbles.

All remaining medicinal product and waste should be destroyed in accordance with established procedures.

Adverse Reactions

The nature and frequency of adverse reactions identified in studies varied depending on the age of the vaccinees.

In clinical trials in children aged 9 to 18 months, within 7 days after vaccination, the most frequently reported were tenderness at the injection site and pain. In clinical trials in children aged 2 to 10 years the most frequently reported were pain and redness at the injection site, irritability, diarrhea, drowsiness, anorexia; in adolescents aged 11 to 18 years and in adults aged 18 to 55 years the most frequently reported were pain at the injection site, headache and increased fatigue.

Revaccination

In adolescents and adults, serious adverse reactions occurred in 1.3% of cases after revaccination with the Menactra^® vaccine. The most common local and systemic reactions reported within 7 days after vaccination were injection site pain (60.2%) and myalgia (42.8%). The average frequency of local and general reactions in adolescents and adults after a single primary immunization and after revaccination with the Menactra^® vaccine did not differ. Most of the reported reactions were mild or moderate in severity and resolved within 3 days.

The frequency of the adverse reactions listed below is classified according to WHO recommendations and includes the following categories: very common (≥10%); common (≥1% and <10%); uncommon (≥0.1% and <1%); rare (≥0.01% and <0.1%); very rare (<0.01%); frequency not known (cannot be estimated from the available data).

Children aged 9 to 18 months inclusive

The safety profile of the Menactra^® vaccine is based on data from four clinical studies in approximately 3700 children aged 9 to 18 months. Safety was assessed during the first 7 days, 30 days, and 6 months after the last immunization.

The majority of reported local reactions observed within 7 days after vaccination were mild to moderate in severity and lasted no more than 3 days. The majority of reported general reactions were mild in severity and lasted no more than 3 days. Adverse reactions are listed in the table below.

Table 1. Frequency of adverse reactions in children aged 9 to 18 months inclusive

Children aged 2 to 10 years inclusive

The safety profile of the Menactra^® vaccine is based on data from three clinical studies in more than 2400 children aged 2 to 10 years.

Safety was assessed during the first 7 days, 28 days, and 6 months after immunization.

The majority of reported local and general reactions observed within 7 days after vaccination were mild in severity. Local reactions lasted on average no more than 3 days, and general reactions lasted on average less than 4 days. Adverse reactions are listed in the table below.

Table 2. Frequency of adverse reactions in children aged 2 to 10 years inclusive

Individuals aged 11-55 years inclusive

The safety profile of the Menactra^® vaccine is based on data from seven clinical studies in more than 7000 adolescents and adults aged 11 to 55 years.

Safety was assessed during the first 7 days, 28 days, and 6 months after immunization.

The majority of reported local and general reactions observed within 7 days after vaccination were mild in severity. Local reactions lasted on average 2 days, and general reactions lasted on average less than 5 days. Adverse reactions are listed in the table below.

Table 3. Frequency of adverse reactions in individuals aged 11 to 55 years inclusive

Post-marketing data

During post-marketing surveillance, additional information was obtained on the following adverse events after administration of the drug (currently, the frequency of these events and their causal relationship with the use of the Menactra^® vaccine cannot be determined).

Table 4. Adverse events in the post-marketing period

Post-marketing safety study

The risk of GBS after administration of the Menactra^® vaccine was assessed in a retrospective cohort study (USA). Medical data of 9,578,688 adolescents aged 11-18 years were analyzed, of which 1,431,906 patients received the Menactra^® vaccine. A total of 72 cases of GBS confirmed by medical records were reported. In all cases, the Menactra^® vaccine was administered to patients more than 42 days before the onset of GBS symptoms. Another 129 cases of GBS were not confirmed or were excluded from the analysis due to lack or insufficiency of medical information. Based on the results of the analysis, which took into account the number of excluded GBS cases, the additional risk of GBS was estimated to range from 0 to 5 additional cases of GBS per 1,000,000 vaccinated individuals within 6 weeks after vaccination.

Contraindications

• Known hypersensitivity to the active substances, to any of the excipients of the vaccine, or allergic reactions after previous administration of this vaccine or a vaccine containing the same components;
• Acute infectious and non-infectious diseases, exacerbation of chronic diseases (in these cases, vaccination is carried out after recovery or during remission).

Use in Pregnancy and Lactation

Pregnancy

Animal studies have not revealed any adverse effects of the Menactra^® vaccine on the course of pregnancy and embryofetal development, the process of childbirth, and postnatal development. Since studies of vaccination in pregnant women have not been conducted, and post-marketing experience of its use in pregnant women is limited, administration of the vaccine to pregnant women is recommended only in case of extreme necessity, such as during an outbreak of meningococcal infection, before traveling to an endemic area, and only after assessing the benefit-risk ratio of vaccination.

Breastfeeding

It is currently unknown whether the active substances contained in the vaccine are able to pass into breast milk. However, it has previously been shown that antibodies to polysaccharides are detected in young mice that were breastfed.

Studies in mice did not demonstrate an adverse effect on the postnatal development of offspring that received antibodies induced by the administration of the Menactra^® vaccine through maternal milk. At the same time, the effects in infants whose mothers were immunized with the Menactra^® vaccine during breastfeeding have not been studied. Before deciding to immunize a breastfeeding woman, the risks and benefits of such immunization should be assessed.

Pediatric Use

Children who have reached the age of 9 months are subject to vaccination.

Geriatric Use

Used in adults up to 55 years of age inclusive.

Special Precautions

Vaccination is especially indicated for the following groups at high risk of meningococcal disease

• 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 properdin and complement component deficiencies;
• Persons with functional or anatomical asplenia;
• Tourists and persons traveling to areas hyperendemic for meningococcal infection, such as sub-Saharan African countries;
• Employees of research, industrial, and clinical laboratories regularly exposed to Neisseria meningitidis in solutions capable of forming an aerosol;
• Students of various universities, and especially those living in dormitories or apartment-type hotels;
• Conscripts and recruits.

It is prohibited to administer the Menactra^® vaccine subcutaneously or intradermally, since data on the safety and efficacy of the vaccine with subcutaneous and intradermal administration are lacking.

It is forbidden to mix the Menactra^® vaccine in the same syringe with other vaccines or drugs.

The vaccine is not intended for the prevention of meningitis caused by other microorganisms, or for the prevention of invasive meningococcal infection caused by meningococci of serogroup B.

As with any vaccination, protective immunity may not develop in 100% of vaccinated individuals.

Although a humoral immune response to diphtheria toxoid may be observed after administration of the Menactra^® vaccine, this vaccine cannot be considered an immunizing agent against diphtheria. It is not recommended to change the schedule of vaccination with standard diphtheria vaccines due to the administration of the Menactra^® vaccine.

The use of the vaccine in persons with thrombocytopenia or coagulation disorders has not been studied. As with other intramuscularly administered vaccines, the benefit-risk ratio of vaccine use in persons at increased risk of bleeding with intramuscular injection should be assessed.

In individuals with impaired immune status, as well as during immunosuppressive therapy, a reduced immune response to the administration of the Menactra^® vaccine may be observed. In the case of immunosuppressive therapy, it is recommended to postpone vaccination until the completion of such therapy.

The risk of developing Guillain-Barré syndrome (GBS) after administration of the Menactra^® vaccine was assessed in a post-marketing retrospective cohort study. Cases of GBS development characterized by a temporal association with the administration of the Menactra^® vaccine have been described. Individuals who have previously been diagnosed with GBS may be at increased risk of developing this condition after administration of the Menactra^® vaccine. The decision to use the Menactra^® vaccine in this situation should be made after assessing the potential benefits and risks.

Before using the vaccine, the healthcare professional or treating physician should inform the patient, their parents, guardians, or other responsible adults about the potential benefits and risks for the patient associated with the administration of the vaccine.

Before administering the vaccine, necessary precautions should be taken to prevent severe adverse reactions, including allergic ones, namely: review the patient’s vaccination history, ascertain the presence of contraindications to immunization, and assess the patient’s current health status.

Vaccine administration is carried out under the supervision of a healthcare professional, and the room where vaccination is performed should have the necessary anti-shock therapy agents available (e.g., epinephrine hydrochloride solution (1:1000) and injectable glucocorticosteroids) in case of an unexpected anaphylactic reaction after vaccine administration.

Cases of fainting have been observed after administration of the Menactra^® vaccine. Measures should be taken to prevent injuries associated with fainting and falling, as well as the possibility of providing medical assistance in case of fainting.

Effect on ability to drive vehicles and operate machinery

No studies have been conducted on the effect of the vaccine on the ability to drive a car and operate other machinery.

Overdose

No cases of overdose have been reported.

Drug Interactions

The Menactra^® vaccine can be used simultaneously with the following vaccines: tetanus, diphtheria, pertussis (acellular), inactivated poliomyelitis, vaccine for the prevention of infections caused by Haemophilus influenzae type b , measles and rubella, typhoid polysaccharide, conjugated pneumococcal vaccine, human papillomavirus vaccines in accordance with their instructions for use and the National Calendar of Preventive Vaccinations and Vaccinations for Epidemic Indications of the Russian Federation (see the “Pharmacological Action” section for data on efficacy and safety for different age groups of vaccinees).

It is allowed to administer the Menactra^® vaccine with other inactivated vaccines on the same day using different syringes in different parts of the body.

When administering the Menactra^® vaccine separately from other inactivated or live vaccines (except BCG), they can be administered with any interval between them. The interval before and after BCG vaccination is 1 month.

When used concomitantly with the diphtheria, tetanus, and pertussis (acellular) vaccine in children aged 4 to 6 years inclusive, it is preferable to administer both vaccines simultaneously, or the Menactra^® vaccine should be administered before the diphtheria, tetanus, and pertussis (acellular) vaccine.

A reduced immune response to the Menactra^® vaccine was demonstrated when it was administered one month after the administration of the diphtheria, tetanus, and pertussis (acellular) vaccine.

Titers of pneumococcal antibodies against some serotypes contained in the 7-valent conjugate vaccine (PCV7) were reduced after simultaneous administration of the Menactra^® vaccine and the PCV7 vaccine.

There are no data on the assessment of the immune response to the administration of the Menactra^® vaccine after the administration of the diphtheria, tetanus, and pertussis (acellular) vaccine in children under 4 years of age or on the administration of the Menactra^® vaccine to persons under 11 years of age after the administration of other vaccines containing diphtheria toxoid.

BCG vaccine should not be used simultaneously with the Menactra^® vaccine.

Before vaccination, the physician should be informed about the recent or concurrent use of another, including over-the-counter, medicinal product.

Concomitant use with general immunosuppressive drugs

In persons undergoing immunosuppressive therapy, the immune response after vaccination may be reduced.

Storage Conditions

The drug should be stored out of the reach of children, in a refrigerator at a temperature of 2°C (35.6°F) to 8°C (46.4°F), in the original packaging (in a cardboard box) to protect from light. Do not freeze. The drug that has been frozen is not suitable for use.

Shelf Life

The shelf life is 24 months. Do not use after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.