Rates of local and systemic side effects with MenQuadfi wereComparable to Menveo* and Menactra

The safety of MenQuadfi has been evaluated in nearly 5000 trial participants 2 years of age and older1

MenQuadfi vs Menveo

Study design: The immunogenicity and safety of MenQuadfi in adolescents 10 through 17 years of age were evaluated in a randomized, head-to- head clinical trial vs Menveo involving more than 1700 participants. Solicited injection site and systemic reactions were recorded by participants daily for 7 days following vaccination. All unsolicited adverse events that occurred within 30 days following vaccination were recorded by participants, and all serious adverse events were collected for at least 6 months after vaccination.1,2

Frequency of solicited injection-site reactions and systemic adverse reactions within 7 days after vaccination with MenQuadfi or Menveo1

MenQuadfi v Menveo % ADVERSE REACTIONS Chart Injection Site Pain 45.2 v 42.5 Injection Site Erythema 5.0 v 7.5 Injection Site Swelling 5.4 v 6.5 Myalgia 35.3 v 35.2 Headache 30.2 v 30.9 Malaise 26.0 v 26.4 Fever 1.4 v 1.2 MenQuadfi v Menveo % ADVERSE REACTIONS Chart Injection Site Pain 45.2 v 42.5 Injection Site Erythema 5.0 v 7.5 Injection Site Swelling 5.4 v 6.5 Myalgia 35.3 v 35.2 Headache 30.2 v 30.9 Malaise 26.0 v 26.4 Fever 1.4 v 1.2 MenQuadfi v Menveo % ADVERSE REACTIONS Chart Injection Site Pain 45.2 v 42.5 Injection Site Erythema 5.0 v 7.5 Injection Site Swelling 5.4 v 6.5 Myalgia 35.3 v 35.2 Headache 30.2 v 30.9 Malaise 26.0 v 26.4 Fever 1.4 v 1.2 MenQuadfi v Menveo % ADVERSE REACTIONS Chart Injection Site Pain 45.2 v 42.5 Injection Site Erythema 5.0 v 7.5 Injection Site Swelling 5.4 v 6.5 Myalgia 35.3 v 35.2 Headache 30.2 v 30.9 Malaise 26.0 v 26.4 Fever 1.4 v 1.2

MenQuadfi vs Menactra

Study design: The immunogenicity and safety of MenQuadfi were evaluated in a randomized, head-to-head clinical trial vs Menactra that included individuals 10-55 years of age (N=3344). Analyses were stratified by age, including a subpopulation consisting of nearly 1400 adolescents 10 through 17 years of age. Solicited injection site and systemic reactions were recorded by participants daily for 7 days following vaccination. All unsolicited adverse events that occurred within 30 days following vaccination were recorded by participants, and all serious adverse events were collected for at least 6 months after vaccination.1,3

Frequency of solicited injection-site reactions and systemic adverse reactions within 7 days after vaccination with MenQuadfi or Menactra1

MenQuadfi v Menactra % ADVERSE REACTIONS Chart Injection Site Pain 34.8 v 41.4 Injection Site Erythema 4.5 v 4.5 Injection Site Swelling 4.1 v 4.8 Myalgia 27.4 v 31.2 Headache 26.5 v 28.0 Malaise 19.4 v 23.9 Fever 0.7 v 0.6 MenQuadfi v Menactra % ADVERSE REACTIONS Chart Injection Site Pain 34.8 v 41.4 Injection Site Erythema 4.5 v 4.5 Injection Site Swelling 4.1 v 4.8 Myalgia 27.4 v 31.2 Headache 26.5 v 28.0 Malaise 19.4 v 23.9 Fever 0.7 v 0.6 MenQuadfi v Menactra % ADVERSE REACTIONS Chart Injection Site Pain 34.8 v 41.4 Injection Site Erythema 4.5 v 4.5 Injection Site Swelling 4.1 v 4.8 Myalgia 27.4 v 31.2 Headache 26.5 v 28.0 Malaise 19.4 v 23.9 Fever 0.7 v 0.6 MenQuadfi v Menactra % ADVERSE REACTIONS Chart Injection Site Pain 34.8 v 41.4 Injection Site Erythema 4.5 v 4.5 Injection Site Swelling 4.1 v 4.8 Myalgia 27.4 v 31.2 Headache 26.5 v 28.0 Malaise 19.4 v 23.9 Fever 0.7 v 0.6

IMPORTANT SAFETY INFORMATION

MenQuadfi should not be administered to anyone who has had a severe allergic reaction to any component of the vaccine, or after a previous dose of MenQuadfi or any other tetanus toxoid-containing vaccine.

Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MenQuadfi. Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (eg, eculizumab) are at increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, W, and Y, even if they develop antibodies following vaccination with MenQuadfi.

Syncope can occur following, or even before, vaccination with MenQuadfi. Procedures should be in place to prevent falling and injury and to manage syncope.

Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to give MenQuadfi to persons with a history of GBS should take into account the expected benefits and potential risks.

Immunization with MenQuadfi does not substitute for routine tetanus immunization.

Vaccination with MenQuadfi may not protect all vaccine recipients.

The most common adverse reactions following a primary dose of MenQuadfi in individuals 2 years of age and older include pain at the injection site; myalgia, headache, and malaise. Other common adverse reactions in children 2 through 9 years of age include erythema and swelling at the injection site. In adolescents and adults, rates of solicited adverse reactions following a booster dose were comparable to those observed following primary vaccination. Other adverse reactions may occur.

Please see the full Prescribing Information for MenQuadfi.

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* MenACWY = Quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccine. Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine).

CI = Confidence interval; N = Number of participants in per-protocol analysis set with valid serology results.1 * Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine). a Defined as the proportion of participants with an hSBA pre-vaccination titer <1:8 who achieved a post-vaccination titer ≥1:8, or participants with a pre-vaccination titer ≥1:8 who achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer.1 b Percent difference: MenQuadfi minus Menveo or Menactra (95% CI).1 c 95% CI of the difference calculated from the Wilson Score method without continuity correction; the overall non-inferiority would be demonstrated if the lower limit of the 2-sided 95% CI is >-10% for all 4 serogroups.1 d 95% CI of the single proportion calculated from the exact binomial method.1 e Defined as the proportion of participants with an hSBA pre-vaccination titer <1:8 who achieved a post-vaccination titer ≥1:16, or pre- vaccination titer ≥1:8 who achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer.3

MenQuadfi is a trademark of Sanofi Pasteur Inc.
Menveo is a registered trademark of Glaxo SmithKline Biologicals S.A.
Menactra is a registered trademark of Sanofi, its affiliates, and its subsidiaries.

N,n = Number of vaccinated participants with available data for the events listed.1 * Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine).

MenQuadfi is a trademark of Sanofi Pasteur Inc. Menveo is a registered trademark of Glaxo SmithKline Biologicals S.A. Menactra is a registered trademark of Sanofi, its affiliates, and its subsidiaries.

* MenACWY = Quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccine.

* ACIP = Advisory Committee on Immunization Practices. MenACWY = Quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccine. CPT (Current Procedural Terminology) is a registered trademark of the American Medical Association.

REFERENCES:

REFERENCE:

1. MenQuadfi [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

REFERENCES:

1.  MenQuadfi [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

2. Chang L-J, Hedrick J, Christensen S, Pan J, Jordanov E, Dhingra MS. A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United States. Vaccine. 2020;38(19):3560-3569.

3. Dhingra MS, Peterson J, Hedrick J, Pan J, Neveu D, Jordanov E. Immunogenicity, safety and inter-lot consistency of a meningococcal conjugate vaccine (MenACYW-TT) in adolescents and adults: A Phase III randomized study. Vaccine. 2020;38(33):5194-5201.

REFERENCES:

1.  MenQuadfi [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

2. Chang L-J, Hedrick J, Christensen S, Pan J, Jordanov E, Dhingra MS. A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United States. Vaccine. 2020;38(19):3560-3569.

3. Dhingra MS, Peterson J, Hedrick J, Pan J, Neveu D, Jordanov E. Immunogenicity, safety and inter-lot consistency of a meningococcal conjugate vaccine (MenACYW-TT) in adolescents and adults: a phase III randomized study. Vaccine. 2020;38 (33):5194-5201.

4. Sanofi Pasteur Inc. Data on File. July 27, 2020.

1. MenQuadfi [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

2. Centers for Disease Control and Prevention (CDC). Vaccines and preventable diseases. https://www.cdc.gov/vaccines/vpd/mening/hcp/about-vaccine.html#types. Reviewed: July 26, 2019. Accessed May 13, 2020.

3. Immunization Action Coalition (IAC). Vaccine timeline.https://www.immunize.org/timeline. Accessed February 5, 2020.

4. Menactra [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

5. 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 May 1, 2020.

1. MenQuadfi [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

2. 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 22, 2020.

3. Elam-Evans LD, Yankey D, Singleton JA, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13–17 years — United States, 2019. MMWR. Morb Mortal Wkly Rep. 2020;69:1109–1116. DOI: http://dx.doi.org/10.15585/mmwr.mm6933a1. Accessed September 2, 2020.

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MAT-US-2007152-v1.0-10/2020 Last Updated: 10/2020