References

  1. Menactra vaccine [Prescribing Information]. Swiftwater, Pennsylvania: Sanofi Pasteur Inc.; 2011.
  2. Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine Preventable Disease. 12th ed. Atlanta, GA: Centers for Disease Control and Prevention; 2011.
  3. Tunkel AR, van de Beek D, Scheld MW. Acute meningitis. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 7th ed. Philadelphia, Pennsylvania: Churchill Livingstone Elsevier; 2010:1189-1229.
  4. US Food and Drug Administration. January 14, 2005 approval letter. http://www.fda.gov/BiologicsBloodVaccines/ Vaccines/ApprovedProducts/ucm131181.htm. Accessed July 22, 2012.
  5. Harrison LH. Epidemiological profile of meningococcal disease in the United States. Clin Infect Dis. 2010;50(suppl 2):S37-S44.
  6. Keyserling H, Papa T, Koranyi K, et al. Safety, immunogenicity, and immune memory of a novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents. Arch Pediatr Adolesc Med. 2005;159(10):907-913.
  7. Sanofi Pasteur Inc. Data on file (Menactra clinical development overview), April 2010. MKT20159.
  8. Sanofi Pasteur Inc. Data on file (Menactra vaccine direct doses distributed by year from 2005 through December 19, 2012), July 2013. MKT25930.

Important Safety Information

Indication

Menactra vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Menactra vaccine is approved for use in individuals 9 months through 55 years of age. Menactra vaccine does not prevent N meningitidis serogroup B disease.

Safety Information

The most common local and systemic adverse reactions to Menactra vaccine include pain, redness, and swelling at the injection site and appetite loss (all age groups); induration at the injection site and diarrhea (all age groups except infants); irritability and drowsiness (infants and children); abnormal crying, vomiting, and fever (infants); headache, fatigue, malaise, and arthralgia (adolescents and adults). Other adverse reactions may occur.

Menactra vaccine is contraindicated in persons with a known hypersensitivity (eg, anaphylaxis) to any component of the vaccine. Persons previously diagnosed with Guillain-Barré syndrome (GBS) may be at increased risk of GBS following receipt of Menactra vaccine. GBS has been reported in temporal relationship following administration of Menactra vaccine. The decision to give Menactra vaccine should be based on careful consideration of the potential benefits and risks. Syncope (fainting) can occur in association with administration of injectable vaccines, including Menactra vaccine. Procedures should be in place to prevent falling injury and manage syncopal reactions. Vaccination with Menactra vaccine may not protect all individuals.

Before administering Menactra vaccine, please see accompanying full Prescribing Information.

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