Initial U.S. Approval: 2010
MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135…
Apnea following intramuscular vaccination has been observed in some infants born prematurely.
[Serious adverse events (SAEs) were reported by up to 3.5% of infants and toddlers among three studies on infants up to 2 years of age.]
The most common SAEs reported in these 3 studies were wheezing, pneumonia, gastroenteritis, and convulsions, and most occurred at highest frequency after the infant series.
In a study of older infants… the rates of SAEs… were… 3.8%…
2 deaths were reported in the groups receiving MENVEO (one case of sudden death and one case of sepsis)…
[W]ithin 42 days of vaccination… recipients of MENVEO… were diagnosed with Kawasaki Disease. One case of acute disseminated encephalomyelitis with symptom onset 29 days post Dose 4 was observed…
SAEs in subjects aged 2 through 10 years… occurring within the first 30 days… were… appendicitis, pneumonia, staphylococcal infection, dehydration, febrile convulsion, and tonic convulsion…
In a supportive study… 7%… had SAEs over a 13-month follow-up period including 13 subjects with varicella and 2 subjects with laryngitis.
SAEs in subjects aged 11 through 55 years… appendicitis… road traffic accident*… and suicide attempt…
The events that occurred during the first 30 days post immunization with MENVEO were: vitello-intestinal duct remnant, Cushing’s syndrome, viral hepatitis, pelvic inflammatory disease, intentional multiple-drug overdose, simple partial seizure, and suicidal depression.
Postmarketing Experience
– Local lymphadenopathy.
– Hearing impaired, ear pain, vertigo, vestibular disorder.
– Eyelid ptosis.
– Injection site pruritus; pain; erythema; inflammation; and swelling, including extensive swelling of the vaccinated limb; fatigue; malaise; pyrexia.
– Hypersensitivity reactions, including anaphylaxis.
– Vaccination site cellulitis.
– Fall, head injury.
– Alanine aminotransferase increased, body temperature increased.
– Arthralgia, bone pain.
– Dizziness*, syncope*, tonic convulsion*, headache, facial paresis, balance disorder.
– Oropharyngeal pain.
– Skin exfoliation.
…Bell’s palsy showed a statistically significant increased risk in the period 1 to 84 days post vaccination…
MENVEO [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] is a sterile liquid vaccine administered by intramuscular injection that contains N. meningitidis serogroup A, C, Y, and W-135 oligosaccharides conjugated individually to Corynebacterium diphtheriae CRM197 protein.
Each dose of vaccine contains 10 mcg MenA oligosaccharide; 5 mcg of each of MenC, MenY, and MenW-135 oligosaccharides; and 25.4 to 65.5 mcg CRM197 protein.
MENVEO has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.