In head-to-head non-inferiority trials, MenQuadfi demonstratedA high immune response across serogroups (A, C, W, and Y)1

MenQuadfi elicited an effective seroresponse across all 4 serogroups vs Menveo®1* and Menactra®†

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. Analyses included more than 900 participants. Serum was collected at baseline and 30 days post vaccination to measure antibodies with a human serum bactericidal assay (hSBA).1

Percentage of subjects achieving vaccine seroresponsea at day 30 (primary endpoint)1

MenQuadfi v Menveo % ACHIEVING hSBA SERORESPONSE Chart SEROGROUP A 76 v 66 SEROGROUP C 97 v 73 SEROGROUP W 86 v 67 SEROGROUP Y 97 v 81 MenQuadfi v Menveo % ACHIEVING hSBA SERORESPONSE Chart SEROGROUP A 76 v 66 SEROGROUP C 97 v 73 SEROGROUP W 86 v 67 SEROGROUP Y 97 v 81 MenQuadfi v Menveo % ACHIEVING hSBA SERORESPONSE Chart SEROGROUP A 76 v 66 SEROGROUP C 97 v 73 SEROGROUP W 86 v 67 SEROGROUP Y 97 v 81
MenQuadfi v Menveo % ACHIEVING hSBA SERORESPONSE Chart SEROGROUP A 76 v 66 SEROGROUP C 97 v 73 SEROGROUP W 86 v 67 SEROGROUP Y 97 v 81

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 to 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. Serum was collected at baseline and 30 days post vaccination to measure antibodies with a human serum bactericidal assay (hSBA).1,2

Seroresponse rates for MenQuadfi were non-inferior to those of Menactra for all serogroups based on the same non-inferiority criteria defined for the MenQuadfi vs Menveo study.1

Percentage of subjects 10-17 years of age achieving vaccine seroresponsea at day 30 (secondary analysis)2

MenQuadfi v Menactra % ACHIEVING hSBA SERORESPONSE Chart SEROGROUP A 74 v 55 SEROGROUP C 96 v 53 SEROGROUP W 85 v 72 SEROGROUP Y 96 v 86 MenQuadfi v Menactra % ACHIEVING hSBA SERORESPONSE Chart SEROGROUP A 74 v 55 SEROGROUP C 96 v 53 SEROGROUP W 85 v 72 SEROGROUP Y 96 v 86 MenQuadfi v Menactra % ACHIEVING hSBA SERORESPONSE Chart SEROGROUP A 74 v 55 SEROGROUP C 96 v 53 SEROGROUP W 85 v 72 SEROGROUP Y 96 v 86 MenQuadfi v Menactra % ACHIEVING hSBA SERORESPONSE Chart SEROGROUP A 74 v 55 SEROGROUP C 96 v 53 SEROGROUP W 85 v 72 SEROGROUP Y 96 v 86

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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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 ≥1:16, 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

MenQuadfi is a registered trademark of Sanofi Pasteur Inc.

Menveo is a registered trademark of GlaxoSmithKline Biologicals S.A.

Menactra is a registered trademark of Sanofi, its affiliates, and its subsidiaries.

REFERENCES:

  1. MenQuadfi [Prescribing Information]. Sanofi Pasteur Inc.
  2. Sanofi Pasteur Inc. Data on File. July 27, 2020.

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