The person depicted is a model used for illustrative purposes only.

SOLICITED ADVERSE REACTIONS IN ADOLESCENT PATIENTS 11 TO 18 YEARS OF AGE WITHIN 7 DAYS POSTVACCINATION1

  MENVEO [n=1631] Menactra [n=539]
Injection-site pain 44% 53%
Erythema [local] 15% 16%
Induration [local] 12% 11%
Headache 29% 28%
Myalgia 19% 18%
Nausea 12% 9%
Malaise 11% 12%
Chills 8% 7%
Arthralgia 8% 6%
Rash* 3% 3%
Fever [≥38°C] 1% 1%

SOLICITED ADVERSE REACTIONS IN INFANT AND TODDLER PATIENTS 2 TO 23 MONTHS OF AGE WHO RECEIVED MENVEO AT 2, 4, 6, AND 12 MONTHS OF AGE WITHIN 7 DAYS AFTER ANY DOSE1

  DOSE 1: 2 months DOSE 2: 4 months
  MENVEO Control MENVEO Control
  [n=1246-1252] [n=427-428] [n=1119-1207] [n=396-399]
Tenderness 41% 45% 31% 36%
Erythema 11% 14% 12% 21%
Induration 8% 16% 9% 17%
Irritability 57% 59% 48% 46%
Sleepiness 50% 50% 37% 36%
Persistent Crying 41% 38% 28% 24%
Change in eating habits 23% 24% 18% 17%
Vomiting 11% 9% 7% 6%
Diarrhea 16% 11% 11% 8%
Rash 3% 3% 3% 4%
Fever ≥38°C [axillary] 3% 2% 4% 6%
  DOSE 3: 6 months DOSE 4: 12 months
  MENVEO Control MENVEO Control
  [n=1050-1058] [n=349-352] [n=1054-1056] [n=333-337]
Tenderness 24% 32% 29% 39%
Erythema 14% 23% 15% 25%
Induration 8% 19% 8% 21%
Irritability 42% 38% 43% 42%
Sleepiness 30% 30% 29% 27%
Persistent Crying 22% 17% 21% 18%
Change in eating habits 17% 13% 19% 16%
Vomiting 6% 4% 5% 4%
Diarrhea 8% 6% 13% 9%
Rash 3% 3% 4% 3%
Fever ≥38°C [axillary] 7% 6% 9% 7%
DOSE 1: 2 months
  MENVEO Control
  [n=1246-1252] [n=427-428]
Tenderness 41% 45%
Erythema 11% 14%
Induration 8% 16%
Irritability 57% 59%
Sleepiness 50% 50%
Persistent Crying 41% 38%
Change in eating habits 23% 24%
Vomiting 11% 9%
Diarrhea 16% 11%
Rash 3% 3%
Fever ≥38°C [axillary] 3% 2%
DOSE 2: 4 months
  MENVEO Control
  [n=1119-1207] [n=396-399]
Tenderness 31% 36%
Erythema 12% 21%
Induration 9% 17%
Irritability 48% 46%
Sleepiness 37% 36%
Persistent Crying 28% 24%
Change in eating habits 18% 17%
Vomiting 7% 6%
Diarrhea 11% 8%
Rash 3% 4%
Fever ≥38°C [axillary] 4% 6%
DOSE 3: 6 months
  MENVEO Control
  [n=1050-1058] [n=349-352]
Tenderness 24% 32%
Erythema 14% 23%
Induration 8% 19%
Irritability 42% 38%
Sleepiness 30% 30%
Persistent Crying 22% 17%
Change in eating habits 17% 13%
Vomiting 6% 4%
Diarrhea 8% 6%
Rash 3% 3%
Fever ≥38°C [axillary] 7% 6%
DOSE 4: 12 months
  MENVEO Control
  [n=1054-1056] [n=333-337]
Tenderness 29% 39%
Erythema 15% 25%
Induration 8% 21%
Irritability 43% 42%
Sleepiness 29% 27%
Persistent Crying 21% 18%
Change in eating habits 19% 16%
Vomiting 5% 4%
Diarrhea 13% 9%
Rash 4% 3%
Fever ≥38°C [axillary] 9% 7%
* Rash was only graded as present or not present without a grading for severity.
MENVEO plus routine vaccinations, including diphtheria toxoid, tetanus toxoid, and acellular pertussis (DTaP), inactivated poliovirus (IPV) types 1, 2, and 3, hepatitis B, Haemophilus influenzae type b (Hib), and 7-valent pneumococcal conjugate (PCV7) at doses 1, 2, 3; and PCV7, measles, mumps, rubella, varicella (MMRV), and hepatitis A vaccines at dose 4. Hepatitis B vaccine (HBV) and rotavirus vaccines were allowed according to Advisory Committee on Immunization Practices (ACIP) recommendations.
Routine vaccinations alone.

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.