IMPORTANT SAFETY INFORMATION
Menactra is contraindicated in persons who have had a severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid-, or CRM197-containing vaccine, or 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. GBS has been reported in temporal relationship following administration of Menactra. The decision to give Menactra 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. Procedures should be in place to prevent falling injury and manage syncopal reactions.
The most common local and systemic adverse reactions to Menactra 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. Vaccination with Menactra may not protect all individuals.
Before administration, please see the full Prescribing Information for Menactra.
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- ACIP = Advisory Committee on Immunization Practices.
- MenACWY = Quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccine.
- hSBA = Serum bactericidal assay using human complement.
- hSBA antibody titers ≥1:8 are considered protective against invasive meningococcal disease.
References: 1. Centers for Disease Control and Prevention (CDC). Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2020. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed April 15, 2020. 2. CDC. Advisory Committee on Immunization Practices recommended immunization schedule for children and adolescents aged 18 years or younger—United States, 2017. MMWR. 2017;66(5):134-135. 3. CDC Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2013;62(RR-2):1-28.
4. Walker TY, Elam-Evans LD, Yankey D, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years—United States, 2018. MMWR. 2019;68(33):718-723. 5. Menactra vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc. 6. Federal Drug Administration. September 4, 2014 approval letter - Menactra [letter]. September 4, 2014. http://wayback.archive-it.org/7993/20170723032500/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm413177.htm. Accessed April 15, 2020. 7. Robertson CA, Greenberg DP, Hedrick J. Pichichero M, Decker MD, Saunders M. Safety and immunogenicity of a booster dose of meningococcal (groups A, C, W and Y) polysaccharide diphtheria toxoid conjugate vaccine. Vaccine. 2016;34(44):5273-5278.