ALTHOUGH UNCOMMON, MENINGOCOCCAL DISEASE MOVES FAST AND IS POTENTIALLY FATAL2

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  • IN AS FEW AS 24 HOURS the symptoms related to meningococcal disease can progress to death in some cases.2
  • 10%-15% DIE from complications associated with meningococcal disease.3
  • Of those who survive, 11%-19% SUFFER permanent consequences—including seizures, limb loss, kidney damage, hearing loss, and skin scarring.3-6
  • 5%-10% OF ADULTS CARRY the bacterium Neisseria meningitidis asymptomatically. Although asymptomatic carriage is common, few carriers develop invasive meningococcal disease. For the majority of people, carriage is an immunizing process that results in systemic, serogroup-specific protective antibody response.7

Meningococcal disease is an uncommon but serious bacterial infection caused by N. meningitidis.7

MENINGOCOCCAL DISEASE STRIKES FAST

Symptoms of meningococcal disease progress rapidly and are often mistaken for the flu in early stages, but can lead to death within 24 hours in some patients.2,8 Please note that symptoms can vary in the order and timing of appearance and some may not appear at all. Symptoms may differ by age group.

TIME AFTER ONSET SYMPTOMS8,*

Headache, sore throat/coryza, leg pain, thirst, general aches, fever8

Decreased appetite, nausea/vomiting, leg pain, irritability8

Rash, drowsiness, difficulty breathing, diarrhea, neck stiffness, cold hands and feet, photophobia, abnormal skin color8

Confusion/delirium, unconsciousness, seizure,† death2,8,‡

 

*Hours expressed as medians, for patients 15-16 years of age.6

†Seizure was noted at a median of 26 hours.6

‡Even with appropriate treatment, the fatality rate is 10%-15% for patients with invasive meningococcal disease.2

Data were obtained from parents of test subjects via questionnaire (n=313) or interview with a study investigator (n=135). Parents were asked at what time of day their child’s symptoms began, as well as the time of appearance of predefined clinical features. Additional data were obtained from medical records for the course of illness before admission to the hospital in 448 children (≤16 years of age) with meningococcal disease (345 nonfatal cases; 103 fatal). Diagnosis was confirmed with microbiologic techniques in 83% of cases (n=373). The remainder of children (n=75) were probable cases.

SEROGROUPS C AND Y CAUSED ALMOST 2/3 OF ALL US MENINGOCOCCAL CASES IN PATIENTS AGED <1 to ≥65 YEARS9,§

§In patients aged <1 to ≥65 years from 2005-2014; N=867.

||Includes serogroup W-135 and serogroups unable to be identified.

INDICATION

MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. MENVEO is approved for use in persons 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections.

IMPORTANT SAFETY INFORMATION FOR MENVEO

  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of MENVEO, any component of this vaccine, or any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine is a contraindication to administration of MENVEO
  • Appropriate medical treatment must be available should an acute allergic reaction, including an anaphylactic reaction, occur following administration of MENVEO
  • Syncope, sometimes resulting in falling injury associated with seizure-like movements, has been reported following vaccination with MENVEO. Vaccinees should be observed for at least 15 minutes after vaccine administration to prevent and manage syncopal reactions
  • Safety and effectiveness of MENVEO have not been evaluated in immunocompromised persons. If MENVEO is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained
  • Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to administer MENVEO to subjects with a known history of GBS should take into account the potential benefits and risks
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including MENVEO, to an infant born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination
  • In clinical trials, common solicited adverse reactions with MENVEO among children initiating vaccination at 2 months of age and receiving the four-dose series were tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea. Common solicited adverse reactions among children initiating vaccination at 7 months through 23 months of age and receiving the two-dose series were tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea. Common solicited adverse reactions among children 2 years through 10 years of age were injection-site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Common solicited adverse reactions among adolescents and adults were pain at the injection site, headache, myalgia, malaise, and nausea. Some events were severe
  • Safety has not been established in pregnant women
  • Vaccination with MENVEO may not result in protection in all vaccine recipients

Please see full Prescribing Information for MENVEO.

825823R0 October 2017

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