Menactra

Each 0.5 mL dose contains 4 mcg of each polysaccharide per serogroup A,C, Y and W-135 conjugated to approximately 48 mcg diphtheria toxoid.
Menactra is a sterile, intramuscularly administered vaccine that contains N. meningitidis serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein. N. meningitidis A, C, Y and W-135 strains are cultured on Mueller Hinton agar and grown in Watson Scherp media. The polysaccharides are extracted from the N. meningitidis cells and purified by centrifugation, detergent precipitation, alcohol precipitation, solvent extraction and diafiltration. To prepare the polysaccharides for conjugation, they are depolymerized, derivatized, and purified by diafiltration. Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium and detoxified with formaldehyde. The diphtheria toxoid protein is purified by ammonium sulfate fractionation and diafiltration. The derivatized polysaccharides are covalently linked to diphtheria toxoid and purified by serial diafiltration. The four meningococcal components, present as individual serogroup-specific glycoconjugates, compose the final formulated vaccine. No preservative or adjuvant is added during manufacture. Each 0.5 mL dose may contain residual amounts of formaldehyde of less than 2.66 mcg (0.000532%), by calculation. Potency of Menactra vaccine is determined by quantifying the amount of each polysaccharide antigen that is conjugated to diphtheria toxoid protein and the amount of unconjugated polysaccharide present.
Menactra vaccine is manufactured as a sterile, clear to slightly turbid liquid. Each 0.5 mL dose of vaccine is formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg each of meningococcal A, C, Y and W-135 polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier.
There is no latex in any component of the vial.
Excipients/Inactive Ingredients: Sodium chloride, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic. The vaccine contains no preservative.

Pharmacology: Mechanism of Action: The presence of bactericidal anti-capsular meningococcal antibodies has been associated with protection from invasive meningococcal disease. Menactra vaccine induces the production of bactericidal antibodies specific to the capsular polysaccharides of serogroups A, C, Y and W-135.
Clinical Studies: Efficacy: The Serum Bactericidal Assay (SBA) used to test sera contained an exogenous complement source that was either human (SBA-H) or baby rabbit (SBA-BR). The response to Menactra vaccination administered to children 9 months through 10 years of age was evaluated by the proportion of participants having an SBA-H antibody titer of 1:8 or greater, for each serogroup. In individuals 11 through 55 years of age, the response to Menactra vaccination was evaluated by the proportion of participants with a 4-fold or greater increase in baseline bactericidal antibody to each serogroup as measured by SBA-BR. For individuals 2 through 55 years of age, vaccine efficacy was inferred from the demonstration of immunologic equivalence to a US-licensed meningococcal polysaccharide vaccine, Menomune - A/C/Y/W-135 vaccine as assessed by Serum Bactericidal Assay (SBA).
Immunogenicity: Immunogenicity in Children 9 through 23 Months of Age: In a randomized, US, multi-center trial, children received Menactra at 9 months and 12 months of age. The first Menactra dose was administered alone, followed by a second Menactra dose given alone (N=404), or with MMRV (N=302), or with PCV7 (N=422). For all participants, sera were obtained approximately 30 days after last vaccination. There were no substantive differences in demographic characteristics between the vaccine groups. The median age for administration of the first dose of Menactra was approximately 9 months. In the primary immunogenicity study, children received Menactra at 9 and 12 months of age, the majority of the participants in groups that received the second dose of Menactra alone or with concomitant pediatric vaccine(s), achieved SBA-HC titers ≥1:8 for all serogroups. Groups that received the second dose of Menactra alone had ≥91% of subjects achieving an SBA-HC titer ≥1:8 for serogroups A, C, and Y and ≥86% for serogroup W-135. When the second dose of Menactra was given concomitantly with MMRV (or MMRV+Hib) or with PCV, the percentages of subjects with SBA-HC titers ≥1:8 were high (>90% for serogroups A, C, and Y and >81% for serogroup W-135). SBA-HC geometric mean titers (GMTs) were high for all serogroups.
An additional study evaluating responses to a 2-dose series of Menactra administered at either 9 and 15 months or at 12 and 15 months of age was conducted. Following the second dose of Menactra in the 9-15 months group, the percentages of participants with hSBA titer ≥1:8 were high for all of the serogroups (>96% for C, Y and W-135 and >85.2% for serogroup A). Similar responses were observed in the 12-15 months group. The percentages of participants with an hSBA titer ≥1:8 were: 85.2% for A; 100.0% for C and >96% for both Y and W-135 serogroups.
Individuals 2 through 55 Years of Age: Immunogenicity was evaluated in three comparative, randomized, US, multicenter, active controlled clinical trials that enrolled children (2 through 10 years of age), adolescents (11 through 18 years of age), and adults (18 through 55 years of age). Participants received a single dose of Menactra vaccine (N=2526) or Menomune - A/C/Y/W-135 vaccine (N=2317). For all age groups studied, sera were obtained before and approximately 28 days after vaccination. (Blinding procedures for safety assessments are described in ADVERSE REACTIONS.)
In each of the trials, there were no substantive differences in demographic characteristics between the vaccine groups, between immunogenicity subsets or the overall study population.
Immunogenicity in Children 2 through 10 Years of Age: Of 1408 enrolled children 2 through 10 years of age, immune responses evaluated by hSBA in a subset of Menactra vaccine participants (2 through 3 years of age, N=52; 4 through 10 years of age, N=84) and Menomune - A/C/Y/W-135 vaccine participants (2 through 3 years of age, N=53; 4 through 10 years of age, N=84), the percentages of subjects with a titer ≥1:8 were constantly higher in the Menactra group for all four serogroups. In the evaluated subset of participants 2 through 3 years of age, the percentage of participants with an hSBA titer ≥1:8 at Day 28 were 73%, Serogroup A; 63%, Serogroup C; 88%, Serogroup Y; 63%, Serogroup W-135 in the Menactra group and 64%, Serogroup A; 38%, Serogroup C; 73%, Serogroup Y; and 33%, Serogroup W-135 in the Menomune group.
In the evaluated subset of participants 4 through 10 years of age, the percentage of participants with an hSBA titer ≥1:8 at Day 28 were 81%, Serogroup A; 79% Serogroup C; 99%, Serogroup Y; 85%, Serogroup W-135 in the Menactra group and 55%, Serogroup A; 48%, Serogroup C; 92%, Serogroup Y; and 79%, Serogroup W-135 in the Menomune group.
Immunogenicity in Adolescents 11 through 18 Years of Age: Results from the comparative clinical trial conducted in 881 adolescents (aged 11 through 18 years) showed that the immune responses measured by SBA-BR to Menactra vaccine and Menomune - A/C/Y/W-135 vaccine were similar for all four serogroups. The percentage of participants with an SBA-BR titer with a ≥4-fold rise from the baseline were 93%, Serogroup A; 92%, Serogroup C; 82%, Serogroup Y; 97%, Serogroup W-135 in the Menactra group and 92%, Serogroup A; 89%, Serogroup C; 80%, Serogroup Y; and 95%, Serogroup W-135 in the Menomune group.
In participants with undetectable pre-vaccination titers (ie, less than 1:8 at Day 0), seroconversion rates (defined as a ≥4-fold rise in Day 28 SBA-BR titers) were similar between the Menactra vaccine and Menomune - A/C/Y/W-135 vaccine recipients. Menactra vaccine participants achieved seroconversion rates of: 100%, Serogroup A; 99%, Serogroup C; 98%, Serogroup Y; 99%, Serogroup W-135. The seroconversion rates for Menomune - A/C/Y/W-135 vaccine recipients were: 100%, Serogroup A; 99%, Serogroup C; 100%, Serogroup Y; 99%, Serogroup W-135.
Immunogenicity in Adults 18 through 55 Years of Age: Results from the comparative clinical trial conducted in 2554 adults aged 18 through 55 years showed that the immune responses measured by SBA-BR to Menactra vaccine and Menomune - A/C/Y/W-135 vaccine were similar for all four serogroups. The percentage of participants with an SBA-BR titer with a ≥4-fold rise from the baseline were 81%, Serogroup A; 89%, Serogroup C; 74%, Serogroup Y; and 89%, Serogroup W-135 in the Menactra group and 85%, Serogroup A; 90%, Serogroup C; 79%, Serogroup Y; and 94%, Serogroup W-135 in the Menomune group. In participants with undetectable pre-vaccination titers (ie, less than 1:8 at Day 0), seroconversion rates (defined as a ≥4-fold rise in Day 28 SBA-BR titers) were similar between the Menactra vaccine and Menomune - A/C/Y/W-135 vaccine recipients.
Menactra vaccine participants achieved seroconversion rates of: 100%, Serogroup A; 99%, Serogroup C; 91%, Serogroup Y; and 97%, Serogroup W-135. The seroconversion rates for Menomune - A/C/Y/W-135 vaccine recipients were: 99%, Serogroup A; 98%, Serogroup C; 97%, Serogroup Y; and 99%, Serogroup W-135.
Concomitant Vaccine Administration: Td: In a double-blind, randomized, controlled trial, 1021 participants aged 11 through 17 years received Td and Menactra vaccines concomitantly (N=509), or Td followed one month later by Menactra vaccine (N=512). Sera were obtained approximately 28 days after each respective vaccination. The proportion of participants with a 4-fold or greater increase in SBA-BR titer to meningococcal Serogroups C, Y and W-135 was higher when Menactra vaccine was given concomitantly with Td (86-96%) than when Menactra vaccine was given one month following Td (65-91%). Anti-tetanus and anti-diphtheria antibody responses were similar in both study groups.
Typhim Vi (Typhoid Vi Polysaccharide Vaccine): In a double-blind, randomized, controlled trial, 945 participants aged 18 through 55 years received Typhim Vi and Menactra vaccines concomitantly (N=469), or Typhim Vi vaccine followed one month later by Menactra vaccine (N=476). Sera were obtained approximately 28 days after each respective vaccination. The antibody responses to Menactra vaccine and to Typhim Vi vaccine components were similar in both study groups.
Non-Clinical Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility: Menactra vaccine has not been evaluated for carcinogenic or mutagenic potential or for impairment of male fertility. A developmental animal toxicity study showed that Menactra had no effects on female fertility in mice (see Use in Pregnancy & Lactation).

Menactra, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra is approved for use in individuals 9 months through 55 years of age. Menactra vaccine is not indicated for the prevention of meningitis caused by other microorganisms or for the prevention of invasive meningococcal disease caused by N. meningitidis serogroup B.

Menactra is administered as a single 0.5 mL injection by the intramuscular route, preferably in the anterolateral thigh or deltoid region depending on the recipient's age and muscle mass.
Primary vaccination: In children 9 through 23 months of age who travel or living in endemic areas. Menactra is given as a 2-dose series at least three months apart.
Individuals 2 through 55 years of age receive a single dose.
Do not administer this product intravenously, subcutaneously, or intradermally. The need for, or timing of, a booster dose of Menactra vaccine has not yet been determined. Parenteral drug products should be inspected visually for container integrity, particulate matter, and discoloration prior to administration, whenever solution and container permit.

Hypersensitivity: Severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM₁₉₇-containing vaccine, or to any component of Menactra vaccine (see DESCRIPTION).
Guillain-Barré Syndrome: Known history of Guillain-Barré syndrome (GBS) is a contraindication to vaccine administration (see PRECAUTIONS).
Febrile or Acute Disease: Vaccination must be postponed in case of febrile or acute disease. However, a minor febrile or non-febrile illness, such as mild upper respiratory infection, is not usually a reason to postpone immunization.
Pregnancy: Refer to Use in Pregnancy & Lactation.

Guillain-Barré Syndrome: Persons previously diagnosed with Guillain-Barré syndrome (GBS) may be at increased risk of GBS following receipt of Menactra. The decision to give Menactra should take into account the potential benefits and risks.
GBS has been reported in temporal relationship following administration of Menactra. The risk of GBS following Menactra vaccination was evaluated in a post-marketing retrospective cohort study [see Post-Marketing Experience under Adverse Reactions].
Preventing and Managing Allergic Vaccine Reactions: Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
Thrombocytopenia or Bleeding Disorders: Menactra vaccine has not been evaluated in persons with thrombocytopenia or bleeding disorders. As with any other vaccine administered intramuscularly, the vaccine risk versus benefit for persons at risk of hemorrhage following intramuscular injection must be evaluated.
Altered Immunocompetence: Reduced Immune Response: Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy may have reduced immune responses to Menactra.
Complement Deficiency: Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N. meningitidis, including invasive disease caused by serogroups A, C, Y and W-135, even if they develop antibodies following vaccination with Menactra.
Limitations of Vaccine Effectiveness: Menactra vaccine may not protect all recipients against vaccine serogroups.
Syncope: Syncope (fainting) has been reported following vaccination with Menactra. Procedures should be in place to prevent falling injury and manage syncopal reactions.
Use in Children: Safety and effectiveness of Menactra vaccine in infants below 9 months of age have not been established.
Use in the Elderly: Safety and effectiveness of Menactra vaccine in adults older than 55 years have not been established.

Pregnancy: Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Menactra during pregnancy.
Risk Summary: All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no adequate and well-controlled studies of Menactra administration in pregnant women in the US. Available data suggest that rates of major birth defects and miscarriage in women who received Menactra 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates.
Menactra vaccine should be given to a pregnant woman only if clearly needed, such as during an outbreak or prior to necessary travel to an endemic area, and only following an assessment involving the healthcare professional and patient of the risks and benefits.
Considering the severity of the meningococcal disease, pregnancy should not preclude vaccination when the risk is clearly identified.
A developmental toxicity study was performed in female mice given 0.1 mL (in divided doses) of Menactra prior to mating and during gestation (a single human dose is 0.5 mL). The study revealed no evidence of harm to the fetus due to Menactra [see Animal Data as follows].
Data: Human Data: A pregnancy registry spanning 11 years (2005-2016) included 222 reports of exposure to Menactra from 30 days before or at any time during pregnancy. Of these reports, 87 had known pregnancy outcomes available and were enrolled in the pregnancy registry prior to the outcomes being known. Outcomes among these prospectively followed pregnancies included 2 major birth defects and 6 miscarriages.
Animal Data: A developmental toxicity study was performed in female mice. The animals were administered 0.1 mL of Menactra (in divided doses) at each of the following time points: 14 days prior to mating, and on Days 6 and 18 of gestation (a single human dose is 0.5 mL). There were no vaccine-related fetal malformations or variations, and no adverse effects on pre-weaning development observed in the study.
Lactation: Risk Summary: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Menactra and any potential adverse effects on the breastfed child from Menactra. Data are not available to assess the effects of Menactra on the breastfed infant or on milk production/excretion.

Clinical Trial Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
Children 9 Through 23 Months of Age: The safety of Menactra was evaluated in four clinical studies that enrolled 3721 participants who received Menactra at 9 and 12 months of age. At 12 months of age these children also received one or more other recommended vaccines [Measles, Mumps, Rubella and Varicella Virus Vaccine Live (MMRV) or Measles, Mumps, and Rubella Virus Vaccine (MMR) and Varicella Virus Vaccine Live (V) each manufactured by Merck & Co., Inc., Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM₁₉₇ Protein) (PCV7), Hepatitis A Vaccine (HepA)]. A control group 997 children was enrolled at 12 months of age and received two or more childhood vaccines [MMRV (or MMR+V), PCV7, HepA] at 12 months of age (see Pharmacology: Clinical Studies: Concomitant Vaccine Administration under Actions). Three percent of individuals received MMR and V, instead of MMRV, at 12 months of age. The primary safety study was a controlled trial that enrolled 1256 children who received Menactra at 9 and 12 months of age. At 12 months of age these children received MMRV (or MMR+V), PCV7 and HepA. A control group of 522 children received MMRV, PCV7 and HepA. Of the 1778 children, 78% of participants (Menactra, N=1056; control group, N=322) were enrolled at United States (US) sites and 22% at a Chilean site. (Menactra, N=200; control group, N=200).
Individuals 2 Through 55 Years of Age: The safety of Menactra was evaluated in eight clinical studies that enrolled 10,057 participants aged 2-55 years who received Menactra and 5266 participants who received Menomune - A/C/Y/W-135 vaccine. The three primary safety studies were randomized, active-controlled trials that enrolled participants 2-10 years of age (Menactra vaccine, N=1713; Menomune - A/C/Y/W-135 vaccine, N=1519), 11-18 years of age (Menactra, N=2270; Menomune - A/C/Y/W-135 vaccine, N=972), and 18-55 years of age (Menactra vaccine, N=1384; Menomune - A/C/Y/W-135 vaccine, N=1170), respectively. Of the 3232 children 2-10 years of age, 68% of participants (Menactra, N=1164; Menomune - A/C/Y/W-135, N=1031) were enrolled at US sites and 32% (Menactra, N=549; Menomune - A/C/Y/W-135, N=488) of participants at a Chilean site. The median ages in the Chilean and US subpopulations were 5 and 6 years, respectively. All adolescents and adults were enrolled at US sites. As the route of administration differed for the two vaccines (Menactra given intramuscularly, Menomune - A/C/Y/W-135 given subcutaneously), study personnel collecting the safety data differed from personnel administering the vaccine.
Safety Evaluation: Participants were monitored after each vaccination for 20 or 30 minutes for immediate reactions, depending on the study. Solicited injection site and systemic reactions were recorded in a diary card for 7 consecutive days after each vaccination. Participants were monitored for 28 days (30 days for infants and toddlers) for unsolicited adverse events and for 6 months post-vaccination for visits to an emergency room, unexpected visits to an office physician, and serious adverse events (SAEs). Unsolicited adverse event information was obtained either by telephone interview or at an interim clinic visit. Information regarding adverse events that occurred in the 6-month post vaccination time period was obtained via a scripted telephone interview.
Serious Adverse Events in All Safety Studies: Serious adverse events (SAEs) were reported during a 6-month time period following vaccinations in individuals 9 months through 55 years of age. In children who received Menactra vaccine at 9 months and at 12 months of age, SAEs occurred at a rate of 2.0% - 2.5%. In participants who received one or more childhood vaccine(s) (without co-administration of Menactra vaccine) at 12 months of age, SAEs occurred at a rate of 1.6% - 3.6%, depending on the number and type of vaccines received. In children 2-10 years of age, SAEs occurred at a rate of 0.6% following Menactra vaccine and at a rate of 0.7% following Menomune - A/C/Y/W-135 vaccine. In adolescents 11 through 18 years of age and adults 18 through 55 years of age, SAEs occurred at a rate of 1.0% following Menactra vaccine and at a rate of 1.3% following Menomune - A/C/Y/W-135 vaccine.
Solicited Adverse Events in the Primary Safety Studies: The most frequently reported solicited injection site and systemic adverse reactions within 7 days following vaccination in children 9 through 23 months of age were injection site tenderness and irritability. The most frequently reported solicited local and systemic adverse reactions in children aged 2-10 years were injection site pain, irritability. Diarrhea, drowsiness, and anorexia were also common. In adolescents ages 11-18 years and adults ages 18-55 years, the most commonly reported reactions were injection site pain, headache, and fatigue. Except for redness in adults, injection site reactions were more frequently reported after Menactra vaccination than after Menomune - A/C/Y/W-135 vaccination.
Adverse Events in Concomitant Vaccine Studies: Solicited Injection Site and Systemic Reactions When Given With Other Pediatric Vaccines: In the primary safety study, 1378 US children were enrolled to receive Menactra vaccine alone at 9 months of age and Menactra vaccine plus one or more other routinely administered vaccines (MMRV, PCV7, and HepA) at 12 months of age (N=961). Another group of children received two or more administered vaccines (MMRV, PCV7, and HepA vaccines) (control group, N=321) at 12 months of age. Participants who received Menactra vaccine and the concomitant vaccines at 12 months of age described previously reported similar frequencies of tenderness, redness, and swelling at the Menactra vaccine injection site and at the concomitant vaccine injection sites. Tenderness was the most frequent injection site reaction (48%, 39%, 46%, and 43% at the Menactra vaccine, MMRV, PCV7, and HepA vaccine sites, respectively). Irritability was the most frequent systemic reaction, reported in 62% of recipients of Menactra vaccine plus concomitant vaccines, and 65% of control group. (See Pharmacology: Clinical Studies: Concomitant Vaccine Administration under Actions.)
Solicited Injection Site and Systemic Reactions When Given With Tetanus and Diphtheria Toxoid Adsorbed Vaccine (Td): In a clinical study, rates of local and systemic reactions after Menactra and Tetanus and Diphtheria Toxoid Adsorbed (Td) vaccine manufactured by Sanofi Pasteur Inc. were compared [see Interactions and Pharmacology: Clinical Studies: Concomitant Vaccine Administration under Actions for study description]. Injection site pain was reported more frequently after Td vaccination than after Menactra vaccination (71% versus 53%). The overall rate of systemic adverse events was higher when Menactra and Td vaccines were given concomitantly than when Menactra vaccine was administered 28 days after Td (59% versus 36%). In both groups, the most common reactions were headache (Menactra vaccine + Td, 36%; Td + Placebo, 34%; Menactra vaccine alone, 22%) and fatigue (Menactra vaccine + Td, 32%; Td + Placebo, 29%; Menactra vaccine alone, 17%). Fever ≥40.0ºC occurred at ≤0.5% in all groups.
Solicited Injection Site and Systemic Reactions When Given With Typhoid Vi Polysaccharide Vaccine: More participants experienced pain after Typhoid vaccination than after Menactra vaccination (Typhoid + Placebo, 76% versus Menactra vaccine + Typhoid, 47%). The majority (70%-77%) of injection site solicited reactions for both groups at either injection site were reported as Grade 1 and resolved within 3 days post-vaccination. In both groups, the most common systemic reaction was headache (Menactra vaccine + Typhoid, 41%; Typhoid + Placebo, 42%; Menactra vaccine alone, 33%) and fatigue (Menactra vaccine + Typhoid, 38%; Typhoid + Placebo, 35%; Menactra vaccine alone, 27%). Fever ≥40.0ºC and seizures were not reported in either group.
Post-Marketing Experience: In addition to reports in clinical trials, worldwide voluntary adverse events reports received since market introduction of Menactra are listed as follows. This list includes serious events and/or events which were included based on severity, frequency of reporting or a plausible causal connection to Menactra. Because these events were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to vaccination.
Blood and Lymphatic System Disorders: Lymphadenopathy.
Immune System Disorders: Hypersensitivity reactions such as anaphylaxis/anaphylactic reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension.
Nervous System Disorders: Guillain-Barre syndrome, paraesthesia, vasovagal syncope, dizziness, convulsion, facial palsy, acute disseminated encephalomyelitis, transverse myelitis.
Musculoskeletal and Connective Tissue Disorders: Myalgia.
General Disorders and Administrative Site Conditions: Large injection site reactions, extensive swelling of the injected limb (may be associated with erythema, warmth, tenderness or pain at the injection site).

Concomitant Administration with Other Vaccines: Menactra vaccine was concomitantly administered with Typhim Vi [Typhoid Vi Polysaccharide Vaccine] (Typhoid) and Tetanus and Diphtheria Toxoids Adsorbed, For Adult Use (Td), in individuals 18 through 55 and 11 through 17 years of age, respectively. And in children younger than 2 years of age, Menactra vaccine was co-administered with one or more of the following vaccines: PCV7, MMR, V, MMRV, HepA, or Hib vaccine [see Pharmacology: Clinical Studies under Actions and Adverse Reactions].
When Menactra was administered concomitantly with PCV, antibody responses to 3 of the 7 serotypes in PCV and to serogroup W-135 of Menactra did not meet the non-inferiority criteria. Given the high antibody response rates to all PCV serotypes when assessed by either ELISA or OPA, and considering that >81% of subjects achieved SBA-HC antibody titers ≥1:8 for all 4 serogroups of Menactra, it is unlikely that there will be any impact on the clinical efficacy of either of these vaccines when administered concomitantly.
Do not mix Menactra vaccine with other vaccines in the same syringe. When Menactra vaccine is administered concomitantly with other injectable vaccines, the vaccines should be administered with different syringes and given at separate injection sites.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses) may reduce the immune response to vaccines.

Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product that has been exposed to freezing should not be used. Do not use after expiration date.
Shelf life: 24 months.

Prior to administration of Menactra vaccine, the healthcare professional should inform the patient, parent, guardian, or other responsible adult of the potential benefits and risks to the patient (see ADVERSE REACTIONS and PRECAUTIONS). Patients, parents or guardians should be instructed to report any suspected adverse reactions to their healthcare professional who should report these events to Sanofi Pasteur Inc.

Vaccines, Antisera & Immunologicals

J07AH08 - meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated ; Belongs to the class of meningococcal bacterial vaccines.

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