sanofi pasteur
 
Menactra® - Meningococcal (Groups A,C,Y and W-135) Polysaccharide Diptheria Toxoid Conjugate Vaccine
Safety Information | Prescribing Information
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Safety

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Demonstrated Safety

  • Adverse reactions to Menactra vaccine are generally mild and consist mainly of injection site pain, redness, and induration; headache, fatigue, and malaise (n=7672)1
  • Local reactions with Menactra vaccine are similar to those following tetanus and diphtheria (Td) vaccine (n=1021)1

Guillain-Barré syndrome (GBS)

Sanofi pasteur is aware of 19 reports of GBS following the administration of Menactra vaccine. We are providing the following Centers for Disease Control and Prevention (CDC) updates to alert health-care professionals to the possible association of GBS with vaccine administration.

We also want to remind you that any reports of GBS should be submitted to the Vaccine Adverse Event Reporting System (VAERS) in a timely manner. Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967. Reporting forms are also available at the FDA Web site at: http://www.vaers.hhs.gov.

Click on the links below to access CDC information about GBS

MMWR June 2005-September 2006: Update: Guillain-Barré syndrome among recipients of Menactra® Meningococcal Conjugate Vaccine–United States.
MMWR October 2005-Feb 2006: Guillain-Barré syndrome among recipients of Menactra® Meningococcal Conjugate Vaccine–United States, (October 2005 –Feb 2006)
MMWR June–July 2005: Guillain-Barré syndrome among recipients of Menactra® Meningococcal Conjugate Vaccine–United States, (June–July 2005)

Additional information about GBS can be found at: http://www.cdc.gov/od/science/iso/gbsfactsheet.htm

References:
1. Menactra Vaccine full Prescribing Information. March 2007.