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SHE’S OUTGROWN
HER FIRST DOSE

IT’S TIME FOR ANOTHER

Are your patients protected from meningococcal disease?

  • ACIPa recommends 16-year-old adolescents receive a 2nd dose of MenACWY1,b
  • About half of adolescents in the US may be at risk of contracting meningococcal disease because they have missed their 2nd dose of MenACWY2,3

Menactra is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Menactra is approved for use in individuals 9 months through 55 years of age. Menactra does not prevent N meningitidis serogroup B disease.4

A single booster dose of Menactra may be given to individuals 15-55 years of age at continued risk for meningococcal disease if at least 4 years have elapsed since the prior dose.4

The most common local and systemic adverse reactions to a primary dose of 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). Overall rates of solicited injection site reactions and solicited systemic reactions following a booster dose of Menactra were similar to those observed in adolescents and adults after a single Menactra dose.4

OUR COMMITMENT TO MENINGOCOCCAL DISEASE

In the US, Sanofi Pasteur has been a leader in this fight for more than 40 years.4-6

 

Sanofi Pasteur Meningococcal Disease timeline Sanofi Pasteur Meningococcal Disease timeline

IT’S TIME FOR A 2ND DOSE

SINCE 2005

  • Menactra was first licensed in 2005 and, in 2014, received FDA approval to be administered as a 2nd dose to adolescents and adults4,6

PRIMARY VACCINATION:

  • In children 9 through 23 months of age, Menactra is given as a 2-dose series,
    3 months apart4
  • In individuals 2 through 55 years of age, Menactra is given as a single dose4

BOOSTER VACCINATION:

  • A single booster dose of Menactra may be given to individuals 15 through
    55 years of age at continued risk for meningococcal disease if at least
    4 years have elapsed since the prior dose4

IMMUNOGENICITY

    Second- and first-dose pivotal data
    are presented below.
    2nd-Dose Immunogenicity in
    Adolescents and Adults4,7

STUDY DESIGN:

    Immunogenicity was studied in a phase 2, open-label study conducted between September 2011 and July 2012 at 15 centers in the US that evaluated the safety and immunogenicity of a single booster dose of Menactra at 4 to 6 years after prior vaccination in persons first vaccinated at 11 through 55 years of age. A total of 834 participants were enrolled; of these, 781 met criteria for inclusion in the per-protocol population for the immunogenicity analysis.4,7
    A 2nd dose of Menactra induced protective titer levels in more than
    99% of trial participants4,7

Immunogenicity 2nd dose chart

Immunogenicity 2nd dose chart

    1st-Dose Immunogenicity in Adolescents4

STUDY DESIGN:

    The immunogenicity and safety of Menactra were evaluated in a head-to-head, randomized, multicenter, active-controlled, non-inferiority US clinical trial vs Menomune – A/C/Y/W-135 that included adolescents 11-18 years of age (N=881). Serum was collected before and approximately 28 days post-vaccination. Participants recorded solicited injection site and systemic reactions over the 7 days following vaccination. Patients reported all unsolicited adverse events that occurred within 30 days following vaccination, while all serious adverse events, emergency room visits, and unexpected visits to an office physician were collected for at least 6 months after vaccination.4
    A first dose of Menactra (N=423) induced seroconversion rates of 81.8% to 96.7%; a first dose of Menomune – A/C/Y/W-135 (N=423) induced seroconversion rates of 80.1% to 95.3%.4

Immunogenicity 1st dose chart

Immunogenicity 1st dose chart

 

SAFETY

    2nd-Dose Safety in Adolescents and Adults4
  • The most common solicited injection site and systemic adverse reactions within 7 days after a second dose of Menactra in adolescent and adult trial participants (median age 17.1 years) were pain (60.2%) and myalgia (42.8%)4
  • Overall rates of solicited injection site reactions and solicited systemic reactions following a second dose were similar to those observed in adolescents and adults after a single Menactra dose. The majority of solicited reactions were Grade 1 or 2 and resolved within 3 days4
    1st-Dose Safety in Adolescents4
    Percentage of participants 11 through 18 years of age reporting solicited adverse reactions within 7 days following a single dose of Menactra vs
    Menomune – A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined)4
First dose adverse reactions, Menactra® [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] vs Menomune® – A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined)

 

First dose adverse reactions, Menactra® [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] vs Menomune® – A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined)

 



NO RECONSTITUTION REQUIRED

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.

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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.
  • Menomune – A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined)
  • N = The number of participants with available data
  • Denotes p<0.05 level of significance. The p-values were calculated for each category and severity using Chi Square test.
  • These solicited adverse events were reported as present or absent only.

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 December 9, 2020. 2. CDC Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2013;62(RR-2):1-28. 3. 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. 4. Menactra vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc. 5. Immunization Action Coalition (IAC). Vaccine timeline. https://www.immunize.org/timeline. Accessed December 9, 2020. 6. Food and 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 December 9, 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.

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MAT-US-2005494-v2.0-12/2020 Last Updated: 12/2020

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.