Meningococcal group A C Y and W-135 Oligosaccharide Diphtheria Conjugate Vaccine

Meningococcal group A C Y and W-135 Oligosaccharide Diphtheria Conjugate Vaccine is used for: Meningococcal infection

Meningococcal Vaccination Indicated active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in high risk adults 0.5 mL/dose IM as a single dose. Primary Vaccination In individuals aged 2 through 55 years, administer as a single dose. Booster Vaccination A single booster dose may be administered to individuals aged 15 through 55 years who are at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of a meningococcal (serogroups A, C, Y, W-135) conjugate vaccine.

Primary Vaccination In children initiating vaccination at 2 months of age, administer as a 4-dose series at 2, 4, 6, and 12 months of age. In children initiating vaccination at 7 months through 23 months of age, administer as a 2-dose series with the second dose administered in the second year of life and at least 3 months after the first dose. In individuals aged 2 through 55 years, administer as a single dose. Booster Vaccination A single booster dose of MENVEO may be administered to individuals aged 15 through 55 years who are at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of a meningococcal (serogroups A, C, Y, W-135) conjugate vaccine.

Administer IM only; do not administer IV, SC, or ID Give IM injection, preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in toddlers, adolescents, and adults

Severe allergic reaction (e.g., anaphylaxis) after a previous dose , any component of this vaccine, or any other CRM197, diphtheria toxoid or meningococcal-containing vaccine is a contraindication to administration

Guillain-Barre syndrome. Preventing & managing allergic vaccine reactions. Thrombocytopenia or bleeding disorders. Immunocompromised person. Pregnancy & lactation.

Pregnancy Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. 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 this vaccine in pregnant women. Available data do not suggest an increased risk of major birth defects and miscarriage in women who received this vaccine within 28 days prior to conception or during pregnancy. A developmental toxicity study was performed in female rabbits administered 0.5 mL (at each occasion) of this vaccine prior to mating and during gestation. A single human dose is 0.5 mL. This study revealed no adverse effects on fetal or pre-weaning development. Data Human Data: A pregnancy exposure registry (2014 to 2017) included 82 pregnancies with known outcomes with exposure within 28 days prior to conception or during pregnancy. Miscarriage was reported for 12.2% of pregnancies with exposure to this vaccine within 28 days prior to conception or during pregnancy (10/82). Major birth defects were reported for 3.6% of live-born infants whose mothers were exposed within 28 days prior to conception or during pregnancy (2/55). The rates of miscarriage and major birth defects were consistent with estimated background rates. Animal Data: In a developmental toxicity study, female rabbits were administered this vaccine by intramuscular injection on Days 29, 15, and 1 prior to mating and on Gestation Days 7 and 20. The total dose was 0.5 mL at each occasion (a single human dose is 0.5 mL). No adverse effects on pre-weaning development up to Postnatal Day 29 were observed. There were no vaccine-related fetal malformations or variations observed. Lactation Risk Summary It is not known whether the vaccine components of this vaccine are excreted in human milk. Data are not available to assess the effects of this vaccine in the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this vaccine and any potential adverse effects on the breastfed child from this vaccine or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

Live vaccines. Reduced immunological response w/ immunosuppresants.

Side effects of Meningococcal group A C Y and W-135 Oligosaccharide Diphtheria Conjugate Vaccine : Common solicited adverse reactions (> 10%) among children initiating vaccination at 2 months of age and receiving the four-dose series were tenderness (24-41%) and erythema at injection site (11-15%), irritability (42-57%), sleepiness (29-50%), persistent crying (21-41%), change in eating habits (17-23%), vomiting (5-11%) and diarrhea (8-16%). Common solicited adverse reactions (>10%) among children initiating vaccination at 7 months through 23 months of age and receiving the two-dose series were tenderness (10-16%) and erythema at the injection site (12-15%), irritability (27-40%), sleepiness (17-29%), persistent crying (12-21%), change in eating habits (12-20%) and diarrhea (10-16%). Common solicited adverse reactions (> 10%) among children 2 years through 10 years of age who received injection site pain (31%), erythema (23%), irritability (18%), induration (16%), sleepiness (14%), malaise (12%), and headache (11%). Common solicited adverse reactions (> 10%) among adolescents and adults who received were pain at the injection site (41%), headache (30%), myalgia (18%), malaise (16%) and nausea (10%).

Presence of bacteriocidal anti-capsular meningococcal antibodies associated with protection from invasive meningococcal disease. Meningococcal serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein carrier. Induces production of bactericidal antibodies directed against the capsular polysaccharides of serogroups A, C, Y and W-135.