Menactra

Meningococcal Vaccines, All Types

Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the patient, parent, or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
Record in the patient's permanent record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine. These actions are required by the National Childhood Vaccine Injury Act of 1986.

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Menactra solution should be clear to slightly turbid.
Menveo and MenQuadfi are a clear, colorless solution that is free from visible foreign particles. If discoloration or visible particulate matter are present, discard the vial or syringe.[30775] [39161]

Menactra, MenQuadfi, and Menveo 1 vial presentation (single vial with a pink cap) are supplied as ready to use solution; reconstitution is not necessary.[30775] [39161]
 
Reconstitution (Menveo 2 vial presentation only)
Use the MenCYW-135 liquid conjugate component (Vial 1, gray cap) to reconstitute the MenA lyophilized conjugate component (Vial 2, orange cap) to form Menveo.
Using a sterile needle and sterile graduated syringe, withdraw the entire contents of the vial of MenCYW-135 liquid conjugate component (Vial 1, gray cap) while slightly tilting the vial.
Slowly transfer the entire contents of the syringe into the MenA lyophilized conjugate component (Vial 2, orange cap). Invert and shake the reconstituted vial until lyophilized conjugate component is completely dissolved.
After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine.
Storage of reconstituted vaccine: If possible, administer immediately after reconstitution; however, reconstituted Menveo may be stored for up to 8 hours at 36 degrees F to 77 degrees F (2 degrees C to 25 degrees C). Do not freeze. Shake well before using. Discard reconstituted vaccine if it has been frozen or not used within 8 hours.[39161]
 
Intramuscular Injection (Menactra, Menveo, and MenQuadfi)
When Daptacel and Menactra are to be given together for children 4 through 6 years, administer the 2 vaccines concomitantly or administer Menactra before Daptacel. Clinical trials found a reduced meningococcal antibody response when Menactra was administered 1 month after Daptacel.[30295]
Do not mix with any other vaccine.
When concomitant administration of other vaccines is required, administer with different syringes and at different sites.[43236]
The preferred injection site is the anterolateral thigh in infants or the deltoid muscle of the upper arm for children, adolescents, and adults. Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk. Also, do not inject into an area that has been or will be used for another injection. A separate injection site is needed.
Carefully observe patients for approximately 15 minutes after administration; syncope may occur.[30775] [39161]

Guillain-Barre syndrome / Delayed / Incidence not known
myelitis / Delayed / Incidence not known
anaphylactic shock / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known

erythema / Early / 12.0-30.2
lymphadenopathy / Delayed / Incidence not known
hypotension / Rapid / Incidence not known
wheezing / Rapid / Incidence not known
dyspnea / Early / Incidence not known

irritability / Delayed / 21.0-56.8
injection site reaction / Rapid / 9.0-53.0
myalgia / Early / 10.0-42.8
fatigue / Early / 38.0-38.0
inconsolable crying / Delayed / 33.3-33.3
drowsiness / Early / 16.0-30.2
anorexia / Delayed / 9.0-30.2
headache / Early / 5.0-29.0
vomiting / Early / 3.0-14.1
malaise / Early / 10.0-14.0
fever / Early / 1.0-12.2
nausea / Early / 5.0-12.0
arthralgia / Delayed / 3.0-8.0
chills / Rapid / 4.0-8.0
diarrhea / Early / 7.0-8.0
rash / Early / 2.0-5.0
paresthesias / Delayed / Incidence not known
urticaria / Rapid / Incidence not known
pruritus / Rapid / Incidence not known
dizziness / Early / Incidence not known
syncope / Early / Incidence not known

Menactra, MenQuadfi, Menveo

Rx

Conjugate vaccine against Neisseria meningitidis serogroups A, C, Y, and W-135
Used for immunization against invasive meningococcal disease
Routine vaccination recommended for adolescents 11 to 18 years of age, preferably with 1 dose at age 11 or 12 years, and a booster dose at 16 years; booster doses may be indicated for individuals who remain at continued risk

0.5 mL IM. For continued protection of persons at high risk for meningococcal disease, ACIP recommends that a booster dose should be given 5 years after primary immunization and repeated every 5 years thereafter.[53760] The FDA-approved product labeling recommends that a single booster dose may be given if at least 4 years have elapsed since the prior dose and the risk of infection continues.[30775] [39161]

0.5 mL IM. Timing of booster dose is dependent on when the primary series was completed and the indication. For routine immunization, a booster dose at age 16 years is recommended if the primary dose was given at age 11 or 12 years. If the primary dose was given at age 13 to 15 years, give a booster dose at age 16 to 18 years. No booster dose is needed if the primary dose was given on or after age 16 years. For continued protection of persons at high risk for meningococcal disease, ACIP recommends that a booster dose should be given 5 years after primary immunization and repeated every 5 years thereafter.[53760] The FDA-approved product labeling recommends that a single booster dose may be given in adolescents 15 years and older if at least 4 years have elapsed since the prior dose and the risk of infection continues.[30775] [39161]

0.5 mL IM. Give the first booster dose 3 years after the primary series and then subsequent doses every 5 years.[53760]

0.5 mL IM. For continued protection of persons at high risk for meningococcal disease, ACIP recommends that a booster dose should be given 5 years after primary immunization and repeated every 5 years thereafter.[53760] The FDA-approved product labeling recommends that a single booster dose may be given if at least 3 years have elapsed since the prior dose and the risk of infection continues.

0.5 mL IM. Timing of booster dose is dependent on when the primary series was completed and the indication. For routine immunization, a booster dose at age 16 years is recommended if the primary dose was given at age 11 or 12 years. If the primary dose was given at age 13 to 15 years, give a booster dose at age 16 to 18 years. No booster dose is needed if the primary dose was given on or after age 16 years. For continued protection of persons at high risk for meningococcal disease, ACIP recommends that a booster dose should be given 5 years after primary immunization and repeated every 5 years thereafter.[53760] The FDA-approved product labeling recommends that a single booster dose may be given in adolescents 13 years and older if at least 3 years have elapsed since the prior dose and the risk of infection continues.

0.5 mL IM. Give the first booster dose 3 years after the primary series and then subsequent doses every 5 years.[53760]

0.5 mL IM as a single dose. ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.

0.5 mL IM as a single dose.[39161] ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

0.5 mL IM as a single dose. ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.

0.5 mL IM as a single dose. For children age 2 to 5 years at continued high risk of meningococcal disease, a second dose may be administered 2 months after the first dose.[39161] ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

0.5 mL IM. Give as a 2-dose series with the second dose given during the second year of life and at least 3 months after the first dose.[39161] [53026]

0.5 mL IM. Give as a 4-dose series with doses given at 2, 4, 6, and 12 months of age.

0.5 mL IM as a single dose.[30775] ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

0.5 mL IM as a single dose.[30775] ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

0.5 mL IM as a 2-dose series with doses given 3 months apart.[30775]

0.5 mL IM as a single dose. ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

0.5 mL IM as a single dose. ACIP recommends a 1- or 2-dose primary series depending on indication and age at first dose receipt.[53760]

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.

Menactra/MenQuadfi/Menveo Intramuscular Inj Sol: 0.5mL, 10-5-5-5mcg
Menveo Intramuscular Inj Pwd F/Sol: 0.5mL, 10-5-5-5mcg

older than 56 years: 0.5 mL IM of MenQuadfi; safety and efficacy of Menactra or Menveo have not been established.
55 years or younger: 0.5 mL IM.

0.5 mL IM of MenQuadfi; safety and efficacy of Menactra or Menveo have not been established.

0.5 mL IM.

10 to 11 years: 0.5 mL IM.
2 to 9 years: 0.5 mL IM of Menactra, MenQuadfi, or Menveo 2-vial presentation; safety and efficacy of Menveo 1-vial presentation have not been established.
1 year: 0.5 mL IM of Menactra or Menveo 2-vial presentation; safety and efficacy of MenQuadfi and Menveo 1-vial presentation have not been established.

9 to 11 months: 0.5 mL IM of Menactra or Menveo 2-vial presentation; safety and efficacy of MenQuadfi and Menveo 1-vial presentation have not been established.
2 to 8 months: 0.5 mL IM of Menveo 2-vial presentation; safety and efficacy of Menactra, MenQuadfi, and Menveo 1-vial presentation have not been established.
1 month: Safety and efficacy have not been established.

Safety and efficacy have not been established.

The presence of bacterial anti-capsular antibodies has been associated with protection from invasive meningococcal disease. Serogroup A, C, W, and Y capsular polysaccharide (Menactra) or oligosaccharides (Menveo) antigens are individually conjugated to diphtheria toxoid protein. The polysaccharide conjugate vaccine (MenQuadfi) is conjugated to tetanus toxoid protein. Polysaccharide vaccines only elicit a B-cell response, so although antibodies are produced, there is no long-term memory. By coupling the polysaccharides to a carrier protein, a T-cell dependent immune response is generated. A polysaccharide conjugated to a protein carrier also stimulates both B-cell immune response and T-helper cell response to the protein carrier, resulting in antibodies to the protein carrier and immune memory. The diphtheria and/or tetanus toxoid protein does not induce immunity to the diphtheria and/or tetanus antigen. Immunization against diphtheria and/or tetanus does not occur after vaccination with the meningococcal diphtheria toxoid conjugate vaccine or the meningococcal tetanus toxoid conjugate vaccine.

The meningococcal conjugate vaccines (Menactra and Menveo) are administered intramuscularly. 
 
Vaccination does not ensure immunity. In a comparison trial of Menveo and Menactra in adults 19—55 years of age, seroresponse rates to each serogroup 28 days after vaccination were obtained. Serogroup-specific anticapsular antibodies with bactericidal activity were measured using pooled human serum that lacked bactericidal activity as the source of exogenous complement (hSBA). Seroresponse was defined as an after vaccination titer of > 1:8 for subjects with a before vaccination hSBA titer of < 1:4 and as an after vaccination titer at least 4-fold higher than baseline for patients with a before vaccination hSBA titer of at least 1:4. For N. meningitidis serogroup A, 67% had a seroresponse with Menveo and 68% had a seroresponse with Menactra. For serogroup C, 67% had a seroresponse with Menveo and 58% had a seroresponse with Menactra. For serogroup W-135, 50% had a seroresponse with Menveo and 41% had a seroresponse with Menactra. For serogroup Y, 56% had a seroresponse with Menveo and 40% had a seroresponse with Menactra. In another trial, immunogenicity of Menactra was compared to Menomune in adults age 18—55 years. Twenty-eight days after a single dose, a 4-fold rise in antibody titers against N. meningitidis serogroups A, C, Y, and W-135 was observed in 80%, 88%, 73%, and 89%, respectively, of Menactra recipients (n = 1280). These results were similar to those observed with Menomune (n = 1098; 84%, 89%, 79%, 94%, respectively). Immune response obtained from using Menactra as a booster was studied in 781 adults and adolescents, age 15—55 years. In this trial, the percentage of vaccine recipients to achieve a >= 4-fold antibody titer by day 28 for serogroups A, C, Y, W-135 were 95%, 95%, 97%, and 96%, respectively.

No adequate and well controlled studies have been conducted in pregnant women and the ability of the meningococcal conjugate vaccine to cause fetal harm or affect the reproductive system is unknown. An analysis of 5,065 women enrolled in clinical studies revealed 37 pregnancies among the 3,952 Menveo recipients and 6 pregnancies in the 1,113 patients treated with Menactra. A follow-up of these women found 7 spontaneous abortions and no congenital abnormalities in the Menveo group and no spontaneous abortions and 1 congenital abnormality (hydrocephalus) in the Menactra group. A pregnancy registry spanning from 2005 to 2016 included 222 reports of Menactra exposure for 30 days before or at any time during pregnancy. Out of the 87 available pregnancy outcomes, 2 major birth defects and 6 miscarriages were reported. The manufacturers recommend use during pregnancy only if clearly needed; however according to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated vaccines to pregnant women does not adversely affect the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. Instruct women who become pregnant at the time of vaccination to report the pregnancy to their health care professional. Health care professionals are encouraged to enroll exposed pregnant women in manufacturer maintain pregnancy registers by contacting Sanofi Pasteur Inc. at 800-822-2463 (for Menactra) or by contacting Novartis at 877-311-8972 (for Menveo).

Data are limited regarding use of the meningococcal conjugate vaccine during breast-feeding and its' excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers. According to the Advisory Committee on Immunization Practices (ACIP), inactivated, polysaccharide vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.